Medical Writer

4 days ago


India The Hird Full time

Hiring for top MNC for Hybrid role for PAN India


  • Location - Pan India
  • Mode - Hybrid (3 days WFO, 2 days WFH)
  • Exp - 4 to 7 Years
  • CER, PSUR & PMCF
  • Notice period not more than 30 days.


Job Description :


  1. Perform CER & Post market documents gap assessment
  2. Ability to draft and review CER, Post market plans & report such as PMS-Plan, PMS Report, PSUR, PMCF Report
  3. Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.
  4. Collaborates with cross functional teams such as PMS, Medical affairs, Literature search, Risk management, R&D, Sales & Marketing, etc.
  5. Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  6. To interpret results and ensure report is in sync with Plan and regulatory guidelines and statistical interpretations,
  7. Alert relevant stakeholders of potential safety issues
  8. Adhering to company policies and procedures and maintaining customer record for tracking and retrieval.
  9. Review the work performed by peers
  10. Co-ordinate with CFTs for ensuring timely input and review of regulatory documents
  11. Overall responsible for achieving Client’s service level expectations
  12. Good interpretation skill for regulatory guidance documents such as 2017/745, Med Dev., QSR, ISO 13485, ISO 14971 etc.
  13. Prior exp in EU MDR Gap assessment and Remediation.


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