Senior Medical Writer

Job Title: Medical Writer Post-Market Surveillance (PMS)

Location: Pune, India

Experience: 3+ Years into medical writing

Salary: Upto 22 LPA

Education Qualification:

• Graduate in

  Biomedical Engineering

  or

  Pharmacy

  , or

  MBBS

• Postgraduate in

  Life Sciences

About the Role:

Medical Writer (PMS)

Key Responsibilities:

1. Draft, review, and update

   PMS Plans

   ,

   PMS Reports/Periodic Safety Update Reports (PSURs)

   ,

   Post-Market Clinical Follow-up Reports (PRER)

   , and

   Canada Summary Reports

   for medical devices.
2. Identify and assess relevant data sources including literature, clinical data, and medical references and incorporate findings into PMS documents.
3. Compile, interpret, and submit clinical and post-market documentation to meet

   international regulatory requirements

   .
4. Collaborate effectively with

   cross-functional teams

   such as PMS, Medical Affairs, Literature Search, Regulatory, Risk Management, R&D, Sales, and Marketing.
5. Support responses to

   regulatory authority inquiries

   and clarification requests related to post-market documentation.

Skills Required:

• Strong understanding of

  post-market surveillance processes

  for medical devices
• Proficiency in

  technical and medical data analysis

• Excellent

  scientific writing and documentation skills

• Familiarity with

  global regulatory submission processes

• Strong attention to detail and ability to interpret clinical and technical information