Medical Writer

0 years

0 Lacs

Posted:2 days ago| Platform: Linkedin logo

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Job Type

Full Time

Job Description

Job Title:


Location:

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Job Overview:


Senior Medical Writer (PMS)


Key Responsibilities:

  • Draft, update, and review

    PMS-related documents such as:
  • PMS Plan
  • PMS Report / PSUR
  • Periodic Review Evaluation Report (PRER)
  • Canada Summary Report
  • Identify and evaluate data sources

    , including literature, clinical evaluations, and post-market data, to ensure compliance with regulatory expectations.
  • Interpret, compile, and submit

    clinical and post-market documentation to regulatory authorities for

    international submissions (EU MDR, Health Canada, etc.)

    .
  • Collaborate cross-functionally

    with teams such as PMS, Medical Affairs, Literature Search, Regulatory Affairs, Risk Management, R&D, and Sales & Marketing.
  • Support in responding

    to regulatory authority inquiries, clarification requests, and audits.
  • Ensure all documents are

    accurate, compliant, and scientifically sound

    as per applicable regulatory guidelines and quality standards.


Required Skills & Competencies:

  • Proven experience in

    Post-Market Surveillance (PMS)

    documentation for

    Medical Devices

    .
  • Strong understanding of

    EU MDR 2017/745

    ,

    ISO 13485

    , and

    MDSAP

    requirements.
  • Expertise in

    regulatory writing, clinical evaluation, and literature review

    .
  • Excellent

    analytical, medical writing, and data interpretation

    skills.
  • Strong communication and collaboration skills with cross-functional teams.
  • Detail-oriented with ability to manage multiple deliverables and meet strict deadlines.

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