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Are you an experienced Senior Medical Writer looking to advance your career in the medical devices industry? A leading organization, 4C Pharma, is hiring skilled writers with strong expertise in CER writing, PSUR, PMS, and medical device regulatory documentation. This is an excellent opportunity for professionals seeking a full-time, onsite role in Hyderabad with immediate joining.
If you have hands-on experience in Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), and EU MDR compliance, this position offers a promising career pathway in regulatory and clinical documentation.
Key Responsibilities
- Author and review CERs, CEPs, PMCF plans/reports, SSCPs, PSURs, and other regulatory documents.
- Analyze safety data from clinical trials, post-market surveillance, complaints, and adverse events.
- Conduct systematic literature searches, benefit–risk assessments, and hazard analyses.
- Collaborate with cross-functional teams including Regulatory, Clinical, QA, and Medical Affairs.
- Ensure strict compliance with EU MDR, MEDDEV 2.7/2.12, ISO 14155, MDCG and IMDRF guidelines.
- Support internal/external audits and regulatory authority responses.
- Prepare training content and support process improvement initiatives.
- Mentor junior writers and foster knowledge sharing.
Preferred Skills & Experience
- 1–3 years of experience in medical device regulatory writing or clinical documentation.
- Strong knowledge of PSUR, PMS, CER, CEP, PMCF, and MAUDE database.
- Excellent analytical, scientific writing, and communication skills.
- Proficiency in Microsoft Office Suite.
- Detail-oriented with strong understanding of device safety reporting.
Educational Qualifications
- Bachelor’s or Master’s in Pharmacy, Life Sciences, Biomedical Sciences, Nursing, or related fields.
- B.Tech/M.Tech in Biomedical, Electronics, or Mechanical Engineering accepted.
Work Mode & Location
- Location: Hyderabad
- Mode: Work from Office
- Experience Required: 2.1 to 4 years
- Notice Period: Immediate to 15 days
Why Join? (Benefits Overview)
- Opportunity to work on high-impact medical device regulatory documents.
- Exposure to global regulatory standards under EU MDR.
- Work with cross-functional medical and regulatory teams.
- Career progression into advanced regulatory & clinical writing roles.
How to Apply
Eligible candidates can send their updated CV to:
📩 hr@4cpharma.com
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