We are hiring Pharma SME – Medical Writing
Experience : 5–8 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.