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Position: Assistant Manager of Regulatory Affairs
Location: Chennai, Tamilnadu, India
Main Duties & Responsibilities:
Responsible for providing support to the Pfizer Biopharmaceuticals Group (PBG) Oncology Business Unit (BU) Global/US Medical Affairs team specifically:
- Performs medical pre-review (reference check) of promotional, sales training and medical to medical materials including but not limited to Health Care Professional (HCP) promotional aids, Web/Social, training material, advertisements, consumer promotions, conventions/ meetings, etc to ensure:
- The claims are accurate, truthful, not misleading, and aligned with Core Claims, Common Technical, and/or other regulatory documents.
- The references are adequate, and they fully support the relevant claims.
- The claims are consistent with the specified reference label used.
- Providing support to the US/Global Medical Affairs group including but not limited to ad-hoc literature searches, reviews, and summaries, preparation of slide decks.
- Develop abstracts, posters, manuscripts, congress presentations, and slide decks for the Oncology BU as per the required needs.
- Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments, and the benefit-risk of Pfizer products.
- Support for major regulatory agency submissions, Clinical Overviews, Health Hazard Assessments, listings, and summarizing the results of the above research to the required standard if needed by the stakeholders.
- Pre-review of therapy area sales training materials and relevant materials by PHI (Patient Health and Impact).
- Supervision and review of promotional, sales training, and medical to medical materials work performed by the associates in order to provide high quality and timely service.
- Ensuring delivery of all required activities within expected timelines and on budget.
- Support for scientific congresses through preparation and review of content and congress reports.
The Medical Manager supports and partners with the US Medical Leads and Global/US Medical Affairs by:
- Pre-review (reference check) of promotional, sales training, and medical to medical materials.
- Creating documents pertaining to clinical data, company data, published literature, and other data to support the maintenance and defense of our products. Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews, and clinical efficacy section in support of Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports (PSURs), Addendum Reports, Health Hazard Assessments (HHAs), critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities if needed by the US/Global Medical teams.
- Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
- Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues.
- Clinical and scientific medical writing, editing, and quality control review (QC) for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures, and submission documents.
- Pharmacovigilance and drug safety writing including Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
- Manuscript writing including researching, organizing, compiling, interpreting and quality checking various types of technical and/or medical information.
- Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.
- Adapting writing to different types of clients and audiences from the health care professionals and technical people to the consumer audience.
- Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
- Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Deliver assigned documents on or before the deadline, alerting project teams in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
- Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
- Writing skills: Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely, and persuasively.
- Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
- Language skills: High fluency in written English and strong functional fluency in spoken English.
- Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
- Interpersonal skills: Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
- Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonization (ICH), Food and Drug Administration (FDA), and European Medical Agencies (EMA) relevant to clinical and safety.
- Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred.
- Epidemiology: Familiarity with epidemiologic principles and concepts is desirable.
- Familiarity with the US promotional material guidelines and regulations is preferred.
- Reports directly to the Senior Medical Manager.
- Works closely with the US Medical Leads and Global/US Medical Affairs.
- Interacts with Regulatory, Safety and Medical Affairs colleagues, Local, Regional, and at a global level.
Qualification: Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.
- 3 to 4 years of relevant experience for medical graduates, PhDs & masters in life sciences/ more than 6 years of relevant experience for science graduates.
- Minimum 3 years of experience in medical writing within an agency, CRO, Pharma / Biotech Company.
- Prior experience in medical content creation or promotional material review is preferred.
- Prior experience in using search tools, developing search strings, and assessing search results is preferred.
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