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Medical Writing L1-2
Hyderabad, Andhra Pradesh
Sanofi Group
Posted 7 days ago
Job Viewed
Job Description
Job Title: Medical Writing
+ Job Location: Hyderabad
+ Grade: L1-2
+ Hiring Manager: Bitumani Borah.
**About the job**
**Strategic context:**
Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history. As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives. Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level.
The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations. This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making.
As part of GTMC, vision of the Omnichannel pillar is the definition of Sanofi-wide best-in-class Omnichannel engagement strategy, including development of standards & best practices across markets and brand teams, as well as executional planning and support of local Omnichannel approaches (including change management). GTMC will also collaborate closely with Digital to provide consistent tools.
Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Scientific Writer in the Content Operations Team, within our Hyderabad Hub, you'll plan and execute market-driven campaigns, make data-driven business recommendations, and create insightful presentations. You'll optimize Omnichannel strategies in SFMC, leveraging your knowledge of campaign automation and data segmentation to provide valuable recommendations.
**Main responsibilities:**
+ The overall purpose and main responsibilities are listed below:
+ To create/review complex and specialized content (branded/unbranded) without supervision; manage end-to-end Omnichannel content creation/repurposing/localization process including supporting designing & enhancement, validation, tagging & upload, deployment, publishing, and dissemination via relevant tools & platforms. Develop and maintain therapeutic area(s), process(es), and compliance expertise for Omnichannel pillar/GTMC. Support background research/literature analysis/due diligence and application of available content insights generated via AI-enabled digital platforms, Search Engine Optimization (SEO)-Search Engine Marketing (SEM), campaign analytics, CX surveys etc. as relevant for enhancing content generation framework and delivering high quality content. Manage multiple projects across multiple franchises or therapeutic areas.
+ Review scientific accuracy checks/validation (including support for Content Powerhouse) performed by junior writers to ensure the scientific and medical accuracy of marketing content with a strong emphasis on compliance with medical, legal and regulatory standards (MLR). Support GenAI/Content Powerhouse initiatives for ideation sessions for content generation; review, edit and refine AI-generated content to meet high-quality standards and brand guidelines; integrate relevant keywords into content without compromising scientific integrity or readability to improve SEO rankings, user engagement, and accuracy; collaborate with the prompt expert to adjust prompts based on content quality, inputs from brand teams and audience engagement; write compelling headlines, calls-to-action, and content sections as needed to supplement AI-generated text; work closely with the graphic designer to ensure text and visuals are integrated seamlessly.
+ Support brand strategy and messaging plan (map stories) and channel agnostic modular content framework. Support modular content/retro modularization, claims and component review, and localization. Leverage GenAI/Content Powerhouse capabilities and implement innovation and agile methodology aligned with Omnichannel/LexMex/GTMC to scale our production of marketing content.
+ Coach junior writers for developing engaging, impactful, SEO-friendly content for websites (Healthcare Professionals & patients), campus portals, social media channels, and Omnichannel campaigns (including but not limited to banners, emails, newsletters, social media content/posts, interactive visual aids, gifs, scrolls, carousals, KOL interview videos/videos/video articles, podcasts, articles/summaries, infographics, slide decks). Collaborate effectively with stakeholders, peers/team to develop, and promote best-in-class customer experience through best-in-class content.
+ **People** : (1) Maintain effective relationship with the stakeholders within the allocated GTMC pillar with an end objective to develop content as per requirement; and (2) Constantly assist junior writers in developing knowledge and sharing expertise (3) Partner with Head/Lead to strengthen capabilities and support individual development plans (4) Collaborate with cross-functional teams in GTMC to build digital transformation/to bring innovative digital solutions (5) Provide proactive recommendations on improving scientific content of the deliverables and play an active role to follow the best practices in relation to processes, communications, project management, documentation and technical requirements
+ **Performance** : (1) Provide content as per agreed timelines and quality and (2) Be a subject matter expert, coach, mentor, and assist fellow writers. Recommend, lead, and implement tactical process improvements within the department and division-wide
+ **Process** : (1) Develop complex scientific content (branded/unbranded); (2) Act as an Omnichannel content expert for the assigned therapeutic area(s); (3) Assist the Content Operations Hub Team in conducting comprehensive content-need analysis; (4) Implement the content plan and associated activities for the year identified for the pillar; (5) Work with selected vendors within the region to deliver the required deliverables as per defined process; (6) Leverage advanced training delivery tools and techniques thereby enhancing the effectiveness of training delivery
+ **Stakeholder** : (1) Work closely with GTMC/Omnichannel pillars (Global, Local, and Hub) to identify content need and assist in developing assigned deliverables and (2) Liaise with cross-functional Omnichannel teams to prepare relevant and customized deliverables
**About you**
+ **Experience** : 2-4 years of experience in content creation in medico-marketing/medical/commercial/Omnichannel domain for the pharmaceutical/healthcare industry/digital platforms; Intermediate-Advanced level expertise in MS PPT/Excel/Word & Adobe is desirable; experience of developing digital content is preferred
+ **Soft skills & Technical skills** Stakeholder management; communication skills; and ability to work independently and within a team environment
+ : As applicable (including but not limited to therapeutic area/domain knowledge exposure; medico-marketing content; and/or project management); MS PPT/Excel/Word & Adobe
+ **Education** : Advanced degree in life sciences/pharmacy/similar discipline or medical degree
+ **Languages** : Excellent knowledge of English language (spoken and written)
**Why choose us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
Play a key role in shaping and optimizing our content strategy, driving business growth and achieving impactful results
**Pursue progress, discover extraordinary**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
+ Job Location: Hyderabad
+ Grade: L1-2
+ Hiring Manager: Bitumani Borah.
**About the job**
**Strategic context:**
Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history. As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives. Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level.
The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations. This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making.
As part of GTMC, vision of the Omnichannel pillar is the definition of Sanofi-wide best-in-class Omnichannel engagement strategy, including development of standards & best practices across markets and brand teams, as well as executional planning and support of local Omnichannel approaches (including change management). GTMC will also collaborate closely with Digital to provide consistent tools.
Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Scientific Writer in the Content Operations Team, within our Hyderabad Hub, you'll plan and execute market-driven campaigns, make data-driven business recommendations, and create insightful presentations. You'll optimize Omnichannel strategies in SFMC, leveraging your knowledge of campaign automation and data segmentation to provide valuable recommendations.
**Main responsibilities:**
+ The overall purpose and main responsibilities are listed below:
+ To create/review complex and specialized content (branded/unbranded) without supervision; manage end-to-end Omnichannel content creation/repurposing/localization process including supporting designing & enhancement, validation, tagging & upload, deployment, publishing, and dissemination via relevant tools & platforms. Develop and maintain therapeutic area(s), process(es), and compliance expertise for Omnichannel pillar/GTMC. Support background research/literature analysis/due diligence and application of available content insights generated via AI-enabled digital platforms, Search Engine Optimization (SEO)-Search Engine Marketing (SEM), campaign analytics, CX surveys etc. as relevant for enhancing content generation framework and delivering high quality content. Manage multiple projects across multiple franchises or therapeutic areas.
+ Review scientific accuracy checks/validation (including support for Content Powerhouse) performed by junior writers to ensure the scientific and medical accuracy of marketing content with a strong emphasis on compliance with medical, legal and regulatory standards (MLR). Support GenAI/Content Powerhouse initiatives for ideation sessions for content generation; review, edit and refine AI-generated content to meet high-quality standards and brand guidelines; integrate relevant keywords into content without compromising scientific integrity or readability to improve SEO rankings, user engagement, and accuracy; collaborate with the prompt expert to adjust prompts based on content quality, inputs from brand teams and audience engagement; write compelling headlines, calls-to-action, and content sections as needed to supplement AI-generated text; work closely with the graphic designer to ensure text and visuals are integrated seamlessly.
+ Support brand strategy and messaging plan (map stories) and channel agnostic modular content framework. Support modular content/retro modularization, claims and component review, and localization. Leverage GenAI/Content Powerhouse capabilities and implement innovation and agile methodology aligned with Omnichannel/LexMex/GTMC to scale our production of marketing content.
+ Coach junior writers for developing engaging, impactful, SEO-friendly content for websites (Healthcare Professionals & patients), campus portals, social media channels, and Omnichannel campaigns (including but not limited to banners, emails, newsletters, social media content/posts, interactive visual aids, gifs, scrolls, carousals, KOL interview videos/videos/video articles, podcasts, articles/summaries, infographics, slide decks). Collaborate effectively with stakeholders, peers/team to develop, and promote best-in-class customer experience through best-in-class content.
+ **People** : (1) Maintain effective relationship with the stakeholders within the allocated GTMC pillar with an end objective to develop content as per requirement; and (2) Constantly assist junior writers in developing knowledge and sharing expertise (3) Partner with Head/Lead to strengthen capabilities and support individual development plans (4) Collaborate with cross-functional teams in GTMC to build digital transformation/to bring innovative digital solutions (5) Provide proactive recommendations on improving scientific content of the deliverables and play an active role to follow the best practices in relation to processes, communications, project management, documentation and technical requirements
+ **Performance** : (1) Provide content as per agreed timelines and quality and (2) Be a subject matter expert, coach, mentor, and assist fellow writers. Recommend, lead, and implement tactical process improvements within the department and division-wide
+ **Process** : (1) Develop complex scientific content (branded/unbranded); (2) Act as an Omnichannel content expert for the assigned therapeutic area(s); (3) Assist the Content Operations Hub Team in conducting comprehensive content-need analysis; (4) Implement the content plan and associated activities for the year identified for the pillar; (5) Work with selected vendors within the region to deliver the required deliverables as per defined process; (6) Leverage advanced training delivery tools and techniques thereby enhancing the effectiveness of training delivery
+ **Stakeholder** : (1) Work closely with GTMC/Omnichannel pillars (Global, Local, and Hub) to identify content need and assist in developing assigned deliverables and (2) Liaise with cross-functional Omnichannel teams to prepare relevant and customized deliverables
**About you**
+ **Experience** : 2-4 years of experience in content creation in medico-marketing/medical/commercial/Omnichannel domain for the pharmaceutical/healthcare industry/digital platforms; Intermediate-Advanced level expertise in MS PPT/Excel/Word & Adobe is desirable; experience of developing digital content is preferred
+ **Soft skills & Technical skills** Stakeholder management; communication skills; and ability to work independently and within a team environment
+ : As applicable (including but not limited to therapeutic area/domain knowledge exposure; medico-marketing content; and/or project management); MS PPT/Excel/Word & Adobe
+ **Education** : Advanced degree in life sciences/pharmacy/similar discipline or medical degree
+ **Languages** : Excellent knowledge of English language (spoken and written)
**Why choose us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
Play a key role in shaping and optimizing our content strategy, driving business growth and achieving impactful results
**Pursue progress, discover extraordinary**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
This advertiser has chosen not to accept applicants from your region.
0
Medical Information Writer
Hyderabad, Andhra Pradesh
Sanofi Group
Posted 12 days ago
Job Viewed
Job Description
_1)_ _Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Ability to execute the MI projects once they are conceptualized with guidance from experienced team members or mangers 8) Demonstrates resolve and urgency to accomplish tasks under the guidance of supervisor. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 9) Develops and maintains Therapeutic Area expertise. 10) Able to conduct quality checks on peer outputs in case of business need11) Collaborates effectively with Global Medical Information teams to execute content plans_
· _People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise._
· _Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality_
· _Process: 1) Can work with minimum supervision to conduct data sanity and produce error free MI project outputs for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Help to manger to design an overall plan of action basis end-customers feedback & improve course content and delivery._
· _Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables._
About you:
· Experience: 2 - 3 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 1 - 2 years of direct medical information experience in a pharmaceutical company
· Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment.
· Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development)
· Education: Advanced degree in life sciences/ pharmacy/ similar discipline, Master in science, MBA or equivalent)
· Languages: Excellent knowledge of the English language (spoken and written)
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
· _People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise._
· _Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality_
· _Process: 1) Can work with minimum supervision to conduct data sanity and produce error free MI project outputs for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Help to manger to design an overall plan of action basis end-customers feedback & improve course content and delivery._
· _Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables._
About you:
· Experience: 2 - 3 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 1 - 2 years of direct medical information experience in a pharmaceutical company
· Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment.
· Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development)
· Education: Advanced degree in life sciences/ pharmacy/ similar discipline, Master in science, MBA or equivalent)
· Languages: Excellent knowledge of the English language (spoken and written)
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
This advertiser has chosen not to accept applicants from your region.
1
Central CRA (Clinical Research Associate)- Registries
Hyderabad, Andhra Pradesh
Sanofi Group
Posted 12 days ago
Job Viewed
Job Description
**Job title** : **_Central CRA (Clinical Research Associate)- Registries_**
+ undefined
+ _Hiring Manager:_ **_Project Lead - ESR and Grants_**
+ _Location:_ **_Hyderabad_**
· _% of travel expected:_ **_Travel required as per business need_**
· _Job type:_ **_Permanent and Full time_**
About the job
**Our Team:**
_Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize_ processes _and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally._
_The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool._
**Main responsibilities:**
The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site.
**1.** **Feasibility Activities:**
o Involvement in the site selection process together with the Registries Team.
**2.** **Study Start-up Activities:**
o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
o Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
o Prepare EC cover letter and any additional materials required (if applicable)
o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
o Prepare the Insurance Certificate application when applicable.
o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
o Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
o Assist with the upload & file of Study Start-up documentation into the eTMF.
o Ensure that all parties are informed about project progress, changes, and any issues that arise.
+ **Site Monitoring:**
+ **Off-Site Visits**
+ Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
+ Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
+ **Onsite (where local hub affiliates are located)**
+ Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
o **Management of the Site Data:**
o Reviews study data from various sources remotely.
o Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.
**4.** **Site Management:**
o Recruitment Follow up on patient enrolment and patient status.
o Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.
o Develops collaborative relationships with investigational sites and other stakeholders as applicable.
o Liaise with Vendor for different activities (startup, onsite monitoring).
**5.** **Safety & Quality:**
+ Assure adequate safety reporting process of the site, and that site is submitting and/or
+ undefined
+ Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.
**6.** **Study administration:**
+ To maintain all the tables, trackers and databases updated to follow the study progress
+ undefined
+ To know and use all the tools needed.
+ Participates in the investigator
+ undefined
+ _Hiring Manager:_ **_Project Lead - ESR and Grants_**
+ _Location:_ **_Hyderabad_**
· _% of travel expected:_ **_Travel required as per business need_**
· _Job type:_ **_Permanent and Full time_**
About the job
**Our Team:**
_Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize_ processes _and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally._
_The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool._
**Main responsibilities:**
The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site.
**1.** **Feasibility Activities:**
o Involvement in the site selection process together with the Registries Team.
**2.** **Study Start-up Activities:**
o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
o Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
o Prepare EC cover letter and any additional materials required (if applicable)
o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
o Prepare the Insurance Certificate application when applicable.
o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
o Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
o Assist with the upload & file of Study Start-up documentation into the eTMF.
o Ensure that all parties are informed about project progress, changes, and any issues that arise.
+ **Site Monitoring:**
+ **Off-Site Visits**
+ Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
+ Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
+ **Onsite (where local hub affiliates are located)**
+ Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
o Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.
o **Management of the Site Data:**
o Reviews study data from various sources remotely.
o Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.
**4.** **Site Management:**
o Recruitment Follow up on patient enrolment and patient status.
o Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.
o Develops collaborative relationships with investigational sites and other stakeholders as applicable.
o Liaise with Vendor for different activities (startup, onsite monitoring).
**5.** **Safety & Quality:**
+ Assure adequate safety reporting process of the site, and that site is submitting and/or
+ undefined
+ Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.
**6.** **Study administration:**
+ To maintain all the tables, trackers and databases updated to follow the study progress
+ undefined
+ To know and use all the tools needed.
+ Participates in the investigator
This advertiser has chosen not to accept applicants from your region.
2
Statistical Programmer-II (FSP)
Hyderabad, Andhra Pradesh
Parexel
Posted 12 days ago
Job Viewed
Job Description
Job Profile Summary
The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.
Job Description
**Key Accountabilities:**
**Project Management:**
+ Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
**Statistical Programming for Assigned Projects:**
+ Deliver best value and high quality service.
+ Check own work in an ongoing way to ensure first-time quality.
+ Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
+ Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
**Training:**
+ Maintain and expand local and international regulatory knowledge within the clinical industry.
+ Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
+ Provide relevant training and mentorship to staff and project teams as appropriate.
**General:**
+ Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
+ Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
+ Proactively participate in process/quality improvement initiatives.
+ Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
**Skills:**
+ Excellent analytical skills.
+ Proficiency in SAS.
+ Knowledge and understanding of the programming and reporting process.
+ Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
+ Ability to learn new systems and function in an evolving technical environment.
+ Ability to manage competing priorities and flexibility to change.
+ Attention to detail.
+ Ability to successfully work as part of a global team.
+ Work effectively in a quality-focused environment.
+ Effective time management in order to meet daily metrics or team objectives.
+ Show commitment to and perform consistently high quality work.
+ Business/operational skills that include customer focus, commitment to quality management, and problem solving.
**Knowledge and Experience:**
+ Competent in written and oral English.
+ Good communication skills.
**Education:**
+ Educated to degree level in a relevant discipline and/or equivalent work experience.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.
Job Description
**Key Accountabilities:**
**Project Management:**
+ Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
**Statistical Programming for Assigned Projects:**
+ Deliver best value and high quality service.
+ Check own work in an ongoing way to ensure first-time quality.
+ Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
+ Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
**Training:**
+ Maintain and expand local and international regulatory knowledge within the clinical industry.
+ Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
+ Provide relevant training and mentorship to staff and project teams as appropriate.
**General:**
+ Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
+ Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
+ Proactively participate in process/quality improvement initiatives.
+ Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
**Skills:**
+ Excellent analytical skills.
+ Proficiency in SAS.
+ Knowledge and understanding of the programming and reporting process.
+ Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
+ Ability to learn new systems and function in an evolving technical environment.
+ Ability to manage competing priorities and flexibility to change.
+ Attention to detail.
+ Ability to successfully work as part of a global team.
+ Work effectively in a quality-focused environment.
+ Effective time management in order to meet daily metrics or team objectives.
+ Show commitment to and perform consistently high quality work.
+ Business/operational skills that include customer focus, commitment to quality management, and problem solving.
**Knowledge and Experience:**
+ Competent in written and oral English.
+ Good communication skills.
**Education:**
+ Educated to degree level in a relevant discipline and/or equivalent work experience.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
This advertiser has chosen not to accept applicants from your region.
3
Senior Clinical Evaluation Medical Writer
Nanakramguda, Andhra Pradesh
Medtronic
Posted 12 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
The Clinical Evaluation Medical Writer on our Endoscopy team plays a key role in developing and updating clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR, SSCP) to support CE Mark submissions and maintain compliance throughout the product lifecycle. This work follows MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745 and involves close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk.
In addition, the writer supports related activities such as summarizing and disseminating clinical literature and other available data to share relevant evidence, while also managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from both internal teams and external healthcare professionals, all under the appropriate guidance of Clinical and Medical Affairs.
Success in this role requires strong skills in scientific writing, literature review, data analysis, and clear communication, along with a proactive and collaborative mindset.
Responsibilities may include the following and other duties may be assigned.
+ Independently creates and maintains clinical evaluation documents (CEP, CER, PMCFP, PMCFR, SSCP) in compliance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance, and company procedures.
+ Supports Medical Information activities by leveraging scientific expertise to research and respond to inquiries from healthcare professionals and internal teams, maintaining related documents and reports.
+ Performs thorough literature searches and reviews clinical evidence from studies, reports, and available post-market data. Summarizes and combines this information to support product submissions, clinical evaluations, and Medical Information inquiries.
+ Reviews scientific materials like abstracts, posters, manuscripts, slides, and promotional content to check for accuracy, proper claims, off-label use, and compliance with company policies.
+ Develops state-of-the-art reports for product families and reviews cross-functional documents such as IFUs and Risk Management files to ensure alignment on safety and risk information.
+ Identifies and reports complaints or adverse events from literature to the Global Complaint Handling team.
+ Creates responses to audit and submission queries and maintains a database of peer-reviewed literature.
+ Collaborates with key stakeholders to drive evidence-based scientific decisions and maintain compliance with regulatory and corporate guidelines.
+ Communicates project timelines, input requirements, and risks clearly and promptly with cross-functional teams.
**Required Knowledge and Experience:**
+ Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
+ May have broad knowledge of project management.
+ Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
The Clinical Evaluation Medical Writer on our Endoscopy team plays a key role in developing and updating clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR, SSCP) to support CE Mark submissions and maintain compliance throughout the product lifecycle. This work follows MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745 and involves close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk.
In addition, the writer supports related activities such as summarizing and disseminating clinical literature and other available data to share relevant evidence, while also managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from both internal teams and external healthcare professionals, all under the appropriate guidance of Clinical and Medical Affairs.
Success in this role requires strong skills in scientific writing, literature review, data analysis, and clear communication, along with a proactive and collaborative mindset.
Responsibilities may include the following and other duties may be assigned.
+ Independently creates and maintains clinical evaluation documents (CEP, CER, PMCFP, PMCFR, SSCP) in compliance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance, and company procedures.
+ Supports Medical Information activities by leveraging scientific expertise to research and respond to inquiries from healthcare professionals and internal teams, maintaining related documents and reports.
+ Performs thorough literature searches and reviews clinical evidence from studies, reports, and available post-market data. Summarizes and combines this information to support product submissions, clinical evaluations, and Medical Information inquiries.
+ Reviews scientific materials like abstracts, posters, manuscripts, slides, and promotional content to check for accuracy, proper claims, off-label use, and compliance with company policies.
+ Develops state-of-the-art reports for product families and reviews cross-functional documents such as IFUs and Risk Management files to ensure alignment on safety and risk information.
+ Identifies and reports complaints or adverse events from literature to the Global Complaint Handling team.
+ Creates responses to audit and submission queries and maintains a database of peer-reviewed literature.
+ Collaborates with key stakeholders to drive evidence-based scientific decisions and maintain compliance with regulatory and corporate guidelines.
+ Communicates project timelines, input requirements, and risks clearly and promptly with cross-functional teams.
**Required Knowledge and Experience:**
+ Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
+ May have broad knowledge of project management.
+ Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
4
Senior Regulatory Affairs Specialst-1
Nanakramguda, Andhra Pradesh
Medtronic
Posted 12 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**A Day in the Life**
In this exciting role as a **Senior Regulatory Affair Specialist** **,** you will have responsibility for developing and implementing compliant regulatory processes within the Regulatory organization
**Job Responsibilities**
+ Set up new process for entering new data - Regulatory Information Management System
+ Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes
+ Keeps abreast of regulatory procedures and changes.
+ Provide requested regulatory data and documents to support tenders
+ Keeps abreast of regulatory procedures and changes.
+ Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
+ Prepare, review, file, and support premarket documents for global registrations for assigned projects.
+ Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
+ Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
+ Compiles all materials required in submissions, license renewal and annual registrations
+ Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance
+ Monitors and improves tracking/control systems
+ Develop Regulatory Strategies for new or modified products for assigned projects.
+ Monitor and provide information pertaining to impact of changes in the regulatory environment.
+ Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
+ Document, consolidate, and maintain oral and written communication with health authorities
+ Prepare internal documents for modifications to devices, when appropriate.
+ Author and/or review regulatory procedures and update as necessary.
+ Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
**Minimum Qualifications**
+ Bachelor's degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
+ 7+ years experiences for RA role in medical device and or pharmaceutical industry
+ Works independently with general supervision on larger, moderately complex projects / assignments.
+ Contributes to the completion of project milestones.
+ Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
+ Ability to quickly establish credibility with all levels of customer base
+ Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making
**Nice to Haves**
+ US and global regulatory affairs knowledge and experience.
+ Experience working with cross-functional teams.
+ Effective verbal and written communication skills both internally and externally.
+ Experience with solving problems and concerns.
+ Experience with project management and adherence to time schedules.
+ Work well under pressure in a dynamic environment.
+ Highly organized, detail-oriented, and efficient.
+ Team player who seeks to help and learn from colleagues seeing the department success as their own
+ Ability to manage projects to completion within and outside of the direct department and company.
+ Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
+ Proactively seeks to develop and become well-versed within the regulatory landscape.
+ RAPS Regulatory Affairs Certification (RAC).
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare further, together.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
**A Day in the Life**
In this exciting role as a **Senior Regulatory Affair Specialist** **,** you will have responsibility for developing and implementing compliant regulatory processes within the Regulatory organization
**Job Responsibilities**
+ Set up new process for entering new data - Regulatory Information Management System
+ Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes
+ Keeps abreast of regulatory procedures and changes.
+ Provide requested regulatory data and documents to support tenders
+ Keeps abreast of regulatory procedures and changes.
+ Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
+ Prepare, review, file, and support premarket documents for global registrations for assigned projects.
+ Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
+ Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
+ Compiles all materials required in submissions, license renewal and annual registrations
+ Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance
+ Monitors and improves tracking/control systems
+ Develop Regulatory Strategies for new or modified products for assigned projects.
+ Monitor and provide information pertaining to impact of changes in the regulatory environment.
+ Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
+ Document, consolidate, and maintain oral and written communication with health authorities
+ Prepare internal documents for modifications to devices, when appropriate.
+ Author and/or review regulatory procedures and update as necessary.
+ Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
**Minimum Qualifications**
+ Bachelor's degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
+ 7+ years experiences for RA role in medical device and or pharmaceutical industry
+ Works independently with general supervision on larger, moderately complex projects / assignments.
+ Contributes to the completion of project milestones.
+ Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
+ Ability to quickly establish credibility with all levels of customer base
+ Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making
**Nice to Haves**
+ US and global regulatory affairs knowledge and experience.
+ Experience working with cross-functional teams.
+ Effective verbal and written communication skills both internally and externally.
+ Experience with solving problems and concerns.
+ Experience with project management and adherence to time schedules.
+ Work well under pressure in a dynamic environment.
+ Highly organized, detail-oriented, and efficient.
+ Team player who seeks to help and learn from colleagues seeing the department success as their own
+ Ability to manage projects to completion within and outside of the direct department and company.
+ Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
+ Proactively seeks to develop and become well-versed within the regulatory landscape.
+ RAPS Regulatory Affairs Certification (RAC).
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare further, together.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
5
Senior Statistical Programmer FSP
Hyderabad, Andhra Pradesh
Cytel
Posted 12 days ago
Job Viewed
Job Description
**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role will work closely with client's Biomarker programming team and is fully remote based in India region.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Support ad-hoc reports
+ Applying understanding/experience on PK/PD related analysis
+ Creating and reviewing submission documents
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ **Experience of PK/PD analysis is a must.**
+ **Experience of oncology or immunology studies preferred.**
+ Strong knowledge in Macros/SQL and study specific macros and utilities.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role will work closely with client's Biomarker programming team and is fully remote based in India region.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Support ad-hoc reports
+ Applying understanding/experience on PK/PD related analysis
+ Creating and reviewing submission documents
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ **Experience of PK/PD analysis is a must.**
+ **Experience of oncology or immunology studies preferred.**
+ Strong knowledge in Macros/SQL and study specific macros and utilities.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
This advertiser has chosen not to accept applicants from your region.
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6
Medical Science Liaison - East India
Hyderabad, Andhra Pradesh
Boehringer Ingelheim
Posted 12 days ago
Job Viewed
Job Description
**The Position**
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role will cover in East India
**READY TO APPLY?**
Click the _"Apply On Company website"_ button. Create an
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role will cover in East India
**READY TO APPLY?**
Click the _"Apply On Company website"_ button. Create an
This advertiser has chosen not to accept applicants from your region.
7
Principal IS Architect - Veeva Vault Platform
Hyderabad, Andhra Pradesh
Amgen
Posted 12 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will set platform-wide architectural guardrails, ensure every Vault shares a scalable, compliant foundation, and translate complex business needs into elegant, reusable designs that accelerate R&D, Quality, Safety, Medical and Commercial outcomes.
**Roles & Responsibilities:**
+ Define and maintain the **enterprise Vault reference architecture** -objects, lifecycles, security, integrations, data models.
+ Lead **high-impact design reviews** for new Vault modules, major enhancements and integrations, ensuring consistency, performance and reuse.
+ Partner with data governance and integration leads to deliver a **canonical data model** and API strategy that supports end-to-end processes.
+ Provide expert guidance on **validation-ready design** , risk scoring and change control to safeguard GxP compliance.
+ Mentor configuration engineers and domain solution architects; publish standards, patterns and best-practice blueprints.
+ Evaluate Veeva road-map features (e.g., new APIs, AI services) and advise on adoption strategy and enterprise impact.
+ Act as a customer concern point for complex production issues, performance tuning and architectural deviations.
+ Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and model
+ Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency
+ Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs
+ Establish and enforce data standards, governance policies, and best practices
+ Provide domain expertise in Veeva Vault to the team, offering guidance on architecture, solution design, and implementation challenges.
+ Provide hands-on technical leadership in resolving complex technical issues and ensuring smooth deployment and system integration
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
+ Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years Business, Engineering, IT or related field
**Preferred Qualifications:**
**Functional Skills:**
**Must-Have Skills:**
+ Strong understanding of architecting and deployment strategies for integrations to Veeva Vault Platforms/Products.
+ Expertise in system integration, including APIs, middleware tools, and data migration between Vault and other systems.
+ Deep expertise in Vault object/lifecycle design, security model and integration patterns.
+ Proven ability to create cross-domain, reusable architectures that scale across multiple Vaults and business functions.
+ Strong grasp of CSV and regulatory requirements; able to embed compliance into design artifacts.
+ Excellent stakeholder-facing communication-able to explain architectural trade-offs to executives and developers alike.
+ Strong knowledge of Data Lake technologies like Databricks, etc.
+ Experience in Mulesoft and Python script development
+ Experience with system integration and IT infrastructure
+ Experience with data, change, and technology governance processes on the platform level
+ Experience working in agile methodology, including Product Teams and Product Development models
+ Proficiency in designing scalable, secure, and cost-effective solutions.
+ Have partner and team management skills
+ Can lead and guide multiple teams to meet business needs and goals
**Good-to-Have Skills:**
+ Experience with adjacent enterprise platforms (Salesforce, SAP, Boomi/Mule, Snowflake) and API management.
+ TOGAF, SAFe Architect, or similar enterprise architecture certification.
+ Exposure to data-governance frameworks (IDMP, SPOR, master data).
+ Good Knowledge of the Global Pharmaceutical Industry
+ Understanding of GxP process
+ Strong solution design and problem-solving skills
+ Strong understanding of technology, function, or platform
+ Experience in developing differentiated and deliverable solutions
+ Ability to analyze client requirements and translate them into solutions
+ Working late hours
Professional Certifications (please mention if the certification is preferred or mandatory for the role):
+ Veeva Vault Platform Administrator (mandatory)
+ Scaled Agile Framework (SAFe) for Teams (mandatory)
+ Scaled Agile Framework (SAFe) - DevOps Practitioner (preferred)
+ ITIL (preferred)
**Soft Skills:**
+ **Excellent leadership and team management skills.**
+ Strong transformation and change management experience.
+ Exceptional collaboration and communication skills.
+ High degree of initiative and self-motivation.
+ Ability to manage multiple priorities successfully.
+ Team-oriented with a focus on achieving team goals.
+ Strong presentation and public speaking skills.
+ Excellent analytical and solving skills
+ Strong verbal and written communication skills
+ Ability to work effectively with global, virtual teams
**Shift Information:**
**This position requires you to work a later shift and may be assigned a second or third shift schedule.** Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.
**Equal opportunity statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will set platform-wide architectural guardrails, ensure every Vault shares a scalable, compliant foundation, and translate complex business needs into elegant, reusable designs that accelerate R&D, Quality, Safety, Medical and Commercial outcomes.
**Roles & Responsibilities:**
+ Define and maintain the **enterprise Vault reference architecture** -objects, lifecycles, security, integrations, data models.
+ Lead **high-impact design reviews** for new Vault modules, major enhancements and integrations, ensuring consistency, performance and reuse.
+ Partner with data governance and integration leads to deliver a **canonical data model** and API strategy that supports end-to-end processes.
+ Provide expert guidance on **validation-ready design** , risk scoring and change control to safeguard GxP compliance.
+ Mentor configuration engineers and domain solution architects; publish standards, patterns and best-practice blueprints.
+ Evaluate Veeva road-map features (e.g., new APIs, AI services) and advise on adoption strategy and enterprise impact.
+ Act as a customer concern point for complex production issues, performance tuning and architectural deviations.
+ Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and model
+ Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency
+ Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs
+ Establish and enforce data standards, governance policies, and best practices
+ Provide domain expertise in Veeva Vault to the team, offering guidance on architecture, solution design, and implementation challenges.
+ Provide hands-on technical leadership in resolving complex technical issues and ensuring smooth deployment and system integration
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
+ Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years Business, Engineering, IT or related field
**Preferred Qualifications:**
**Functional Skills:**
**Must-Have Skills:**
+ Strong understanding of architecting and deployment strategies for integrations to Veeva Vault Platforms/Products.
+ Expertise in system integration, including APIs, middleware tools, and data migration between Vault and other systems.
+ Deep expertise in Vault object/lifecycle design, security model and integration patterns.
+ Proven ability to create cross-domain, reusable architectures that scale across multiple Vaults and business functions.
+ Strong grasp of CSV and regulatory requirements; able to embed compliance into design artifacts.
+ Excellent stakeholder-facing communication-able to explain architectural trade-offs to executives and developers alike.
+ Strong knowledge of Data Lake technologies like Databricks, etc.
+ Experience in Mulesoft and Python script development
+ Experience with system integration and IT infrastructure
+ Experience with data, change, and technology governance processes on the platform level
+ Experience working in agile methodology, including Product Teams and Product Development models
+ Proficiency in designing scalable, secure, and cost-effective solutions.
+ Have partner and team management skills
+ Can lead and guide multiple teams to meet business needs and goals
**Good-to-Have Skills:**
+ Experience with adjacent enterprise platforms (Salesforce, SAP, Boomi/Mule, Snowflake) and API management.
+ TOGAF, SAFe Architect, or similar enterprise architecture certification.
+ Exposure to data-governance frameworks (IDMP, SPOR, master data).
+ Good Knowledge of the Global Pharmaceutical Industry
+ Understanding of GxP process
+ Strong solution design and problem-solving skills
+ Strong understanding of technology, function, or platform
+ Experience in developing differentiated and deliverable solutions
+ Ability to analyze client requirements and translate them into solutions
+ Working late hours
Professional Certifications (please mention if the certification is preferred or mandatory for the role):
+ Veeva Vault Platform Administrator (mandatory)
+ Scaled Agile Framework (SAFe) for Teams (mandatory)
+ Scaled Agile Framework (SAFe) - DevOps Practitioner (preferred)
+ ITIL (preferred)
**Soft Skills:**
+ **Excellent leadership and team management skills.**
+ Strong transformation and change management experience.
+ Exceptional collaboration and communication skills.
+ High degree of initiative and self-motivation.
+ Ability to manage multiple priorities successfully.
+ Team-oriented with a focus on achieving team goals.
+ Strong presentation and public speaking skills.
+ Excellent analytical and solving skills
+ Strong verbal and written communication skills
+ Ability to work effectively with global, virtual teams
**Shift Information:**
**This position requires you to work a later shift and may be assigned a second or third shift schedule.** Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.
**Equal opportunity statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Affairs Associate Director
Hyderabad, Andhra Pradesh
Amgen
Posted 12 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
Role description:
Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization.
The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
Role description:
Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization.
The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into
This advertiser has chosen not to accept applicants from your region.
9