7,096 Safety Writer jobs in India
Principal Safety Writer
Posted today
Job Viewed
Job Description
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
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Clinical Development | Fortrea
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Efficiency in conducting literature searches for authoring various types of reports
- Write and review various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned
- Perform/ review Signal detection activities
- Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
- Author/ review Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned
- Author/ review Investigator Brochures, Protocols, Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
- Author/ review manuscripts, abstracts, posters for conferences
- Prepare/review medical information responses for HCPs
- Act as a writing coach devise training programs
- Author/review SOPs/WIs/process documents or sections as applicable
- Impart/conduct Trainings for peers and team members
- Coordinate activities related to various types of report writing across a team of writers if applicable
- Liaise with client and act as a primary point of contact for all report writing activities
- Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
- Assist in estimation of resource requirement and responding to RFPs as needed
- Internal and external (client) communication & co-ordination to get the required inputs
- Get resolution on issues affecting project deliverables
- Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides
- Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document
- Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Safety Writer Ii
Posted today
Job Viewed
Job Description
Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery of safety writing deliverables ranging from low to medium complexity through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of higher complexity deliverables. Effectively collaborates with various parties, including but not limited to: PVG project team members, wider PPD/Evidera project team members, client contacts and third party vendors.
Essential function:
Conducts data review, authoring, and quality review tasks on, and project
manages a wide range of clinical trial and marketed product safety writing
deliverables. These include low complexity (e.g. line listing reports; Periodic
Adverse (Drug) Experience Reports (PA(D)ERs)) and moderate complexity (e.g.
Development Safety Update Reports (DSURs), Periodic Safety Update Reports
(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk
Management Plans (dRMPs)) deliverables.
May additionally support authoring of high complexity (Risk Management Plans
(RMPs), marketing authorisation dossier content, customized safety writing
deliverables and regulatory authority assessment report responses) deliverables
under supervision from more senior staff.
Uses multiple company and client systems. Interacts with project team members
and clients.
Operates in a lead capacity, serving as the primary point of contact for assigned
safety writing deliverables. Provides assistance in the development of program
and departmental procedural documents. Mentors less experienced staff.
Ensures that assigned safety writing and project management tasks are
conducted in accordance with company policies and procedures, contractual
agreements and applicable regulations.
Reviews regulatory/pharmacovigilance publications and information sources to
keep updated on current regulations, practices and procedures.
Participates in departmental initiatives
Performs routine project implementation and coordination activities for assigned
safety writing projects, including leading kick-off meetings, managing
communications and data requests, participating in client meetings, audits and
inspections, and reviewing metrics and budgets.
Job Complexity:
Works on problems of diverse scope where analysis of data requires evaluation of
identifiable factors.
Job Knowledge:
A seasoned, experienced professional with a full understanding of area of
specialization; resolves a wide range of issues in creative ways. This job is the fully
qualified, career-oriented, journey-level position.
Supervision Received:
Normally receives little instruction on day-to-day work, general instructions on new
assignments. Demonstrates good judgment in selecting methods and techniques for
obtaining solutions.
Business Relationships:
Represents the department as a prime contact on projects. Interacts with internal
and external personnel on significant matters often requiring coordination between
functional areas. Networks with senior internal and external personnel in own area
of expertise.
**Qualifications**:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
Thorough attention to detail; strong data interpretation and medical-scientific writing skills
Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Skilled at complex project administration including budget activities and forecasting
Strong oral and written English language communication skills, including paraphrasing skills
Solid computer skills with the ability to work within multiple systems; proficient in use of Microsoft
Office products (including Outlook, Word, and Excel)
In-depth understanding of the global regulatory requirements pertaining to pharmacovigilance and
the importance of and compliance with procedural documents and regulations
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to attain a shared goal
Medical Writer – Aggregate Safety Reports
Posted 4 days ago
Job Viewed
Job Description
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Job Description:
We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team! The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
- Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
- Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data(text/number) within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
- Assist junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
- Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
- Responsible for continuous process improvement in the team for developing content.
- Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
- Responsible to participate in assigned training programmes relevant to the job.
- Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
- Control/reduce effort, cycle time and error rates in projects.
- Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
- Provide peer review for colleagues in support of all documents.
- Interface with clients on a regular basis to meet their expectations.
- Orientation Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specifications.
Qualifications:
- Medical/M. Pharm/Pharm D/Life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
Your impact:
About you:
- Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports
Must have:
- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
- Excellent written and verbal communication skills.
- Excellent organizational and time management skills.
- Excellent data interpretation and presentation skills.
- Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
Nice to have:
- Strong interpersonal skills and the ability to be flexible in varying environments
- Good mentoring skills.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Medical Writer – Aggregate Safety Reports
Posted today
Job Viewed
Job Description
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Job Description:
We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team! The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
- Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
- Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data(text/number) within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
- Assist junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
- Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
- Responsible for continuous process improvement in the team for developing content.
- Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
- Responsible to participate in assigned training programmes relevant to the job.
- Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
- Control/reduce effort, cycle time and error rates in projects.
- Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
- Provide peer review for colleagues in support of all documents.
- Interface with clients on a regular basis to meet their expectations.
- Orientation Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specifications.
Qualifications:
- Medical/M. Pharm/Pharm D/Life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
Your impact:
About you:
- Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports
Must have:
- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
- Excellent written and verbal communication skills.
- Excellent organizational and time management skills.
- Excellent data interpretation and presentation skills.
- Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
Nice to have:
- Strong interpersonal skills and the ability to be flexible in varying environments
- Good mentoring skills.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Medical Writer – Aggregate Safety Reports
Posted 4 days ago
Job Viewed
Job Description
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Job Description:
We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team! The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data(text/number) within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
Assist junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
Responsible for continuous process improvement in the team for developing content.
Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
Responsible to participate in assigned training programmes relevant to the job.
Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
Control/reduce effort, cycle time and error rates in projects.
Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
Provide peer review for colleagues in support of all documents.
Interface with clients on a regular basis to meet their expectations.
Orientation Compliance to quality, confidentiality and security.
Adhere and follow quality systems, processes and policies.
Comply to training and specifications.
Qualifications:
Medical/M. Pharm/Pharm D/Life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
Your impact:
About you:
Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports
Must have:
Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
Excellent written and verbal communication skills.
Excellent organizational and time management skills.
Excellent data interpretation and presentation skills.
Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
Nice to have:
Strong interpersonal skills and the ability to be flexible in varying environments
Good mentoring skills.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Medical Writer – Aggregate Safety Reports
Posted 1 day ago
Job Viewed
Job Description
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Job Description:
We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team! The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
- Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
- Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data(text/number) within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
- Assist junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
- Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
- Responsible for continuous process improvement in the team for developing content.
- Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
- Responsible to participate in assigned training programmes relevant to the job.
- Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
- Control/reduce effort, cycle time and error rates in projects.
- Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
- Provide peer review for colleagues in support of all documents.
- Interface with clients on a regular basis to meet their expectations.
- Orientation Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specifications.
Qualifications:
- Medical/M. Pharm/Pharm D/Life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
Your impact:
About you:
- Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports
Must have:
- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
- Excellent written and verbal communication skills.
- Excellent organizational and time management skills.
- Excellent data interpretation and presentation skills.
- Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
Nice to have:
- Strong interpersonal skills and the ability to be flexible in varying environments
- Good mentoring skills.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Content Writer/SEO Content Writer
Posted today
Job Viewed
Job Description
Job Title: Content Writer/SEO Content Writer
Location: Mohali, Punjab
Experience: 6 months to 2 years (on-site)
Job Summary
Our client is seeking a skilled Content Writer/SEO Content Writer to create engaging and optimized content for various platforms. The ideal candidate will have 6 months to 2 years of experience in content creation, SEO, and research. This is a full-time opportunity based in Mohali, Punjab.
Key Responsibilities:
- Conduct in-depth research on industry-related topics to develop original content
- Create engaging content for blogs, articles, product descriptions, social media, and the company website
- Assist the marketing team in developing content for advertising campaigns
- Proofread and edit content to ensure error-free and high-quality output
- Optimize content for search engines using SEO best practices
- Develop compelling headlines and body copy to capture target audience's attention
Requirements
- Strong research and writing skills
- Experience in creating SEO-optimized content
- Familiarity with content management systems and Google's latest algorithms
- Excellent communication and editing skills
- Ability to work in a fast-paced environment and handle multiple projects
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Content Writer
Posted 1 day ago
Job Viewed
Job Description
About Collegesathi :-
Collegesathi is a fast-growing EdTech company delivering online MBAs, diplomas, master’s programs, and certificates. We empower learners with flexible online options and industry-focused credentials. Join our Jaipur team to scale impact and fuel student success.
Role Overview :-
We are looking for a creative and detail-oriented Content Writer to join our Edu-Tech team. The role involves creating engaging, informative, and student-friendly content that enhances learning experiences and supports our brand communication.
Key Responsibilities:
- Write clear, concise, and engaging content for blogs, website, email campaigns, social media, and product descriptions.
- Develop academic and learning-related content (articles, scripts, FAQs, etc.) tailored to the target audience.
- Collaborate with subject matter experts, designers, and marketing teams to produce high-quality content.
- Optimize content using SEO best practices to drive traffic and improve search rankings.
- Edit and proofread content to ensure accuracy, clarity, and brand consistency.
- Stay updated with the latest trends in education, EdTech, and digital content strategies.
Requirements:
- Bachelor’s degree in English, Journalism, Mass Communication, Education, or related field.
- 1–3 years of experience as a Content Writer (preferably in the Edu-Tech industry).
- Strong command of English (grammar, vocabulary, and writing style).
- Ability to simplify complex topics into easy-to-understand content.
- Knowledge of SEO and digital content trends.
- Creativity, research skills, and attention to detail.
Preferred Skills (Good to Have):
- Experience with Learning Management Systems (LMS) or e-learning platforms.
- Familiarity with tools like WordPress, Canva, Grammarly, or SEO tools.
- Basic understanding of instructional design or curriculum writing.
What We Offer:
- Opportunity to create meaningful content that impacts learners.
- A collaborative, innovative, and growth-oriented work culture.
- Competitive salary and performance-based incentives.
Content Writer
Posted 1 day ago
Job Viewed
Job Description
In this role you will help us produce high-quality, engaging content for various digital platforms, create content for blogs, articles and social media requirements.
Job Location: Pune, Maharashtra
Job Description:
· Collaborate with the marketing team to develop content strategies that align with our marketing
and business goals.
· Creating content that informs, educates, and engages our target audience while adhering to our
brand guidelines.
Required Skillset:
· Should be skilled in detail-oriented writing process.
· Strong writing and editing skills.
· Should possess basic SEO knowledge.
Responsibilities and Duties:
· Create blogs and case studies.
· Ensure timely delivery of deliverables.
· Write crisp, SEO-friendly copy for website pages, landing pages, and emails.
· Create whitepapers, eBooks, and customer stories as needed.
· If required work with the lead gen team to create compelling content for ads, and landing pages, of the lead gen campaign.
Qualifications & Characteristics:
· Excellent command of the English language.
· Highly organized and detail-oriented with strong research skills.
· Strong writing, editing, and proofreading skills.
· 1 to 2 years of experience in the B2B domain will be an additional advantage.
Additional Perks:
· Flexible working hours
· Hybrid option available
Content Writer
Posted 1 day ago
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Job Description
We are looking for a creative and detail-oriented Content Writer to produce high-quality, engaging, and original content that aligns with our brand voice and business objectives. You will play a key role in creating content that educates, informs, and inspires our audience across digital platforms.
Key Responsibilities
- Write, edit, and proofread clear, compelling, and grammatically sound content for blogs, websites, social media, newsletters, case studies, and marketing campaigns.
- Conduct in-depth research on industry-related topics to ensure accuracy and relevance.
- Collaborate with marketing, design, and product teams to develop content strategies.
- Optimize content for SEO to improve search visibility and organic traffic.
- Maintain brand tone, style, and messaging consistency across all content.
- Repurpose long-form content into bite-sized content for multiple platforms.
- Stay updated on industry trends, competitors, and content best practices.
Requirements
- Bachelor’s degree in English, Journalism, Communications, Marketing, or related field.
- 2–5 years of proven experience as a Content Writer, Copywriter, or in a similar role.
- Strong writing, editing, and proofreading skills with a keen eye for detail.
- Familiarity with SEO best practices and content management systems (e.g., WordPress).
- Ability to adapt writing style for different formats and audiences.
- Excellent research skills and ability to grasp complex topics quickly.
- Strong organizational and time-management skills.