188 Pharmaceutical jobs in Hyderabad

**_Job_** **_Details_**
**Description**
Underwriter
Key Responsibilities
Conducts risk assessments and follows NLG Underwriting philosophies by analyzing data, using tools (e.g. medical records, prescription databases, borrowing history, credit rating etc.), and third party information (e.g. medical records, prescription databases, borrowing history, credit rating etc.) to protect NLG bottom line and maintain profitability by avoiding fines and putting good risk on the books.
Proactively seeks information (e.g. processes, philosophies, etc.), takes advantage of both formal and informal educational opportunities (e.g. medical and mentoring discussions, etc.) to build the foundations of a solid Underwriting career and continuously expand knowledge, skills, and abilities.
Coordinates and communicates (verbal and written) with internal and external constituents to gather information, gain insights, and explain Underwriter decisioning and works to build relationships in a way that demonstrates seamless service excellence.
Participates in interdepartmental presentations, helps with new hire training in various subjects. At the higher levels of Underwriting, will guide and educate others to improve Underwriting quality, capabilities, efficiencies, and output.
Identifies, communicates, and resolves escalations to deliver on seamless service and protect the bottom line.
Factors that lead to success in this role:
+ You get excited, and feel rewarded, in helping people (Customer Focus)
+ You bounce back from setbacks easily (Being Resilient)
+ You tackle tough assignments, face difficult issues, and challenge the status quo with courage
+ You readily and easily adapt to people and situations, using appropriate empathy (Situational Adaptability, Empathy)
+ You relate comfortably with different types of people and easily build rapport and long-standing relationships (Interpersonal Savvy)
+ You use a mixture of analysis, wisdom, experience, and judgement to make sound decisions (Decision Quality)
+ You can clearly convey your message verbally and written (Communicates effectively), and demonstrates strong listening skills
+ You use business knowledge and experience to guide actions (Business insights)
+ You deal constructively with problems that do not have clear answers, appropriately handling risk (Manages Ambiguity)
+ You are great at multi-tasking in a fast-paced, production environment and are technology savvy (web searches, MS Office, data bases, and Mainframes)
**Minimum Qualifications:**
+ Bachelor's degreepreferred, andminimum 2yearsLifeUnderwriting experience in production-oriented environment required
+ Must be able to pass a background check

**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 with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
+ Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation"and other regulations
+ Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
+ Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
+ Provide vendor oversight to support data sharing and document redaction, as appropriate
+ Provide CRO oversight to support document redaction
+ Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
+ Manage and track redaction book-of-work; compile and report on volume and performance metrics
+ Provide operational support to CT Results Managers, as required
+ Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements"
+ Communicate with internal and external stakeholders to improve on processes and manage unmet need"
+ Train new staff and develops job aids, work instructions, and user guides, as needed"
+ **Specific Knowledge, Skills, Abilities:**
+ Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies "
+ Familiarity and comfortability working with and discussing scientific data
+ Project and stakeholder management experience ""
+ Demonstrated ability to work independently and seek out support when needed""
+ Exceptional written and oral communication skills""
+ Strong organizational skills with the ability to multitask and prioritize
+ **Education/Experience/ Licenses/Certifications:**
+ MA/MS in scientific or medical field
+ 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :52:29.293 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Let's do this. Let's change the world. In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor's degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential.
**Responsibilities:**
+ Provide technical solutions to programming problems within CfOR(Centre for Observational research).
+ Lead and develop technical programming and process improvement initiatives within CfOR
+ Represent the programming function and participate in multidisciplinary project team meetings
+ Project manage programming activities, according to agreed resource and timeline plans
+ Ensure programming activities adhere to departmental standards and SOPs
+ Write and/or review and approve programming plans
+ Write and/or review and approve analysis dataset specifications
+ Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
+ Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
+ Write, test, validate and execute department-, product- and protocol-level macros and utilities
+ Oversee the work of outsourced resources assigned to projects
+ Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
+ Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
+ Participate in the recruitment of programming staff
+ Actively participate in external professional organizations, conferences and/or meetings
+ Provide input to and participate in intra-departmental and CfOR meetings
+ Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
+ Manage staff performance and oversee staff assignments and utilization
+ Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
+ Bachelor's degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
+ Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience
**Preferred Qualifications:**
+ Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
+ Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model.
Experience:
+ Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
+ Team management
+ Global collaboration
+ Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery
+ Statistical programming: SQL required; SAS or R required; Python preferred
+ Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
Key Competencies
+ Hands-on programming and lead role
+ Expert statistical programming knowledge using SAS or R
+ Required: SAS or R
+ Required: SQL
+ Preferred: Python
+ Excellent verbal and written communication skills in English
+ Ability to have efficient exchanges with colleagues across geographical locations
+ Agile project management
+ Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
+ OMOP common data model
+ Drug development life cycle
+ Statistics and basic epidemiology: Incidence and prevalence
+ (Required for Regulatory RWE role): CDISC (SDTM, ADaM)
+ Scientific / technical excellence
+ Oral and written communication, documentation skills
+ Leadership
+ Innovation
+ Teamwork
+ Problem solving
+ Attention to detail
**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**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**

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.

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**
**Regulatory Affairs Specialist**
In this exciting role as a **Regulatory Affair Specialist** **,** you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization.
**Operating Unit**
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.
With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.
**Careers That Change Lives**
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities - and grow as we grow.
**Day in the Life**
Responsibilities include but are not limited to the following:
+ Liason with OU Regulatory to ensure accurate application of processes and assignment of data attributes
+ Conversion of Technical Documents to Global Submission Summary Documentation (GSSD).
+ Creation of e-BOM structure in CAP Agile for GSSD.
+ Streamline Processes through use of Artificial Intelligence.
+ Monitors and remains in compliance with multiple Quality Management Systems.
+ Keeps abreast of regulatory procedures and changes.
**Must Have: Minimum Requirements**
+ Bachelor's degree in Medical, Mechanical, Life Science or other healthcare related major.
+ 4-7 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.
+ Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
+ Flexible working hours - Times will be required to be work in US EST time zone.
**Nice to Have**
+ 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.
**Physical Job Requirements**
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
**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

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**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of 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.
**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

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**
Responsibilities may include the following and other duties may be assigned.
+ Clinical
+ Collects, maintains, archives, and retrieves necessary source documents to ensure compliance with applicable SOPs and complete Scientific communication deliverables
+ Supports leadership in compiling necessary documents and other tasks during audits
+ Supports submission related activities which may include but not limited to CAP Agile upload and Veeva review/upload
+ Assist in the development and execution of meetings between internal and external cross-functional partners
+ Develops mechanisms for monitoring project progress and for intervention and problem-solving with leadership.
+ Assists in tracking and reporting on metrics related to medical writing and information deliverables services to leadership
+ Regulatory Technical Communications
+ Creates, reviews, and reproduces text required for labeling medical products.
+ Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
+ Monitors changes in labeling regulations in the US and/or abroad.
+ Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
+ Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools, and/or policies.
**SPECIALIST CAREER STREAM:** An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Most of the time is spent delivering and overseeing the projects while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Entry-level individual contributor on a project or work team. Works with close supervision.
**Organizational Impact:** Delivers work of limited scope, typically smaller, less complex projects, or related activities.
**Innovation and Complexity:** Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
**Communication and Influence:** Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
**Leadership and Talent Management:** N / A - job at this level is focused on self-development.
**Required Knowledge and Experience:** Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A), 2-4 years of experience required.
**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

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