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.
Job Title
Pharma SME (Medical Writing)