We are hiring Pharma SME Medical Writing
Experience: 58 years
Industry: Pharmaceutical
Shift Timing: 2 pm to 11 pm
Locations: Pune/Bangalore/Lucknow
Key Responsibilities:
- Develop, review, and finalize scientific and regulatory documents including clinical study reports (CSRs), protocols, investigator brochures (IBs), and safety narratives.
- Ensure all documents adhere to ICH-GCP, regulatory, and company standards.
- Translate complex clinical data into clear, concise, and scientifically accurate documents.
- Collaborate with cross-functional teams including clinical research, medical affairs, and regulatory affairs for content accuracy.
- Provide guidance and mentorship to junior medical writers and ensure quality control of deliverables.
Skills & Competencies:
- Proficiency in scientific writing and regulatory documentation.
- Sound understanding of clinical trial phases, statistical concepts, and medical terminology.
- Strong editorial, grammar, and formatting skills with attention to detail.
