Senior Medical Writer

1 week ago


Pune, India The HIRD Full time

Job Title: Medical Writer – Post-Market Surveillance (PMS)Location: Pune, IndiaExperience: 3+ Years into medical writingSalary: Upto 22 LPAEducation Qualification:Graduate in Biomedical Engineering or Pharmacy, or MBBSPostgraduate in Life SciencesAbout the Role:We are looking for a skilled Medical Writer (PMS) with hands-on experience in drafting and managing post-market surveillance (PMS) documentation for medical devices. The ideal candidate should possess strong analytical and writing skills, as well as the ability to interpret technical, clinical, and medical data to support global regulatory submissions.Key Responsibilities: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.Identify and assess relevant data sources — including literature, clinical data, and medical references — and incorporate findings into PMS documents.Compile, interpret, and submit clinical and post-market documentation to meet international regulatory requirements.Collaborate effectively with cross-functional teams such as PMS, Medical Affairs, Literature Search, Regulatory, Risk Management, R&D, Sales, and Marketing.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 devicesProficiency in technical and medical data analysisExcellent scientific writing and documentation skillsFamiliarity with global regulatory submission processesStrong attention to detail and ability to interpret clinical and technical information



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