Senior Medical Writer

1 week ago


Delhi, 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 inBiomedical EngineeringorPharmacy , orMBBSPostgraduate inLife SciencesAbout the Role:We are looking for a skilledMedical Writer (PMS)with hands-on experience in drafting and managing post-market surveillance (PMS) documentation formedical 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 updatePMS Plans ,PMS Reports/Periodic Safety Update Reports (PSURs) ,Post-Market Clinical Follow-up Reports (PRER) , andCanada Summary Reportsfor 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 meetinternational regulatory requirements .Collaborate effectively withcross-functional teamssuch as PMS, Medical Affairs, Literature Search, Regulatory, Risk Management, R&D, Sales, and Marketing.Support responses toregulatory authority inquiriesand clarification requests related to post-market documentation.Skills Required:Strong understanding ofpost-market surveillance processesfor medical devicesProficiency intechnical and medical data analysisExcellentscientific writing and documentation skillsFamiliarity withglobal regulatory submission processesStrong attention to detail and ability to interpret clinical and technical information


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