• Job Description

  Req#: 4882827

  MAIN REPONSIBILITIES / DUTIES

  Responsible for providing support to Global Medical Excellence & Innovation (GME&I), Global Technology & Engineering (GT&E), Worldwide Safety and Regulatory teams, specifically:

  • Work independently, author high quality deliverables to support combination product post-production periodic review and activities associated with the maintenance phase of combination products.
  • Coordinate/assemble information which may be sourced cross functionally.
  • Independently research literature databases (PubMed/EMBASE), and internal and external repositories to support the evaluation of the benefit-risk of Pfizer products.
  • Evaluate competitive landscape and on a periodic basis analyze changes to the state-of-the-art.
  • Review the applicable processes, analyze and complete the following inputs:
    • Design Changes
    • Commitment Tracking (CT) Records
    • Competitor information
    • Corrective and Preventive Action (CAPA)
    • Supplier Corrective Action Request (SCAR)
    • Complaint Trends review by product with a deep-dive into Device Engineering Investigation data
    • Market Actions
  • Perform Risk Management File reviews as part of Post-Production Combination product review.

  The Medical Manager supports and partners with cross functional stakeholders including GT&E, Quality, Safety, Regulatory, and Global Medical Affairs by:

  • Providing support on assigned tasks for the combination products.
  • Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the GT&E 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

  Technical:

  • Regulatory knowledge: Familiarity with global regulatory guidance especially:
    • International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA)
    • AAMI TIR105 Risk management guidance for combination products
    • ISO 13485:2016 Medical Devices-Quality Management Systems—Requirements for Regulatory Purposes
    • US Food and Drug Administration (FDA) regulations published in 21 CFR part 820.30
    • ISO 14971:2019 Medical Devices-Application of Risk Management to Medical Devices
    • ISO/TR 24971:2020 Medical Devices-Guidance on the Application of ISO 14971
  • 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, 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.
  • Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred.

  Managerial:

  • Reports directly to the Senior Medical Manager.
  • Works closely with GT&E and Quality team colleagues at regional and global level.

  Education:

  • Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Biomedical Engineering or equivalent degrees.

  Experience:

  • Medical writing experience in the medical devices and/or combination products domain is mandatory.
  • 5 years relevant experience for medical graduates and PhDs; 7 years relevant experience for science graduates/biomedical engineers. Minimum 4 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.

  
  Work Location Assignment: Flexible
  

  Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

  Medical

  #LI-Remote #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

Notice