14 April, 2022
MAIN REPONSIBILITIES / DUTIES
Responsible for providing support to Pfizer Biopharmaceuticals Group (PBG), Pfizer Global Supply (PGS), Worldwide Safety and Regulatory teams, specifically:
- Supporting all combination medical devices in PBG with regards to providing medical input into Post-Production Product Reviews, specifically:
- Perform clinical literature searches and analysis
- Evaluate product defects and risks associated with the manufacturing, testing and packaging of the product
- Analyze changes to the generally acknowledged State of the Art
- Support activities associated with the maintenance phase of combination medical devices.
- Authoring and Quality Check (QC) of key deliverables for combination products (and medical devices); analysis of post-market surveillance (PMS) data. Support for major regulatory agency submissions, perform literature searches, and summarizing the results of the above research to the required standard.
- Perform Risk Management File reviews as part of Post-Production Combination product review.
- Authoring support for clinical evaluation deliverables including periodic updates of clinical evaluation reports and post-market clinical follow-up evaluation reports.
The Associate Medical Manager supports and partners with cross functional stakeholders including PGS, Quality, Safety, Regulatory, and Global Medical Affairs by:
- Providing support on assigned tasks for the medical devices and combination products.
- Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the PGS Lead, the author proposes or contributes to strategies to resolve any identified issues.
- Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- To work collaboratively with team members and to align with agreed timelines. Effectively manage own time and workload.
- Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
Required Skill Set
- 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.
- Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA), Medical Device Regulation (MDR), 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.
- Reports directly to the Senior Medical Manager.
- Works closely with PGS and Quality team colleagues at regional and global level.
- Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.
- Medical writing experience in the medical devices and combination products domain is mandatory.
- 3 years relevant experience for medical graduates and PhDs; 5 years relevant experience for science graduates. Minimum 3 years of experience in medical writing within an agency, CRO, Pharma / Biotech Company.
- Prior experience in using search tools, developing search strings and assessing search results is preferred.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply through this Link