Pharma SME

3 weeks ago


Pune, India UsefulBI Corporation Full time

We are hiring Pharma SME – Medical Writing Experience: 5–8 yearsIndustry: PharmaceuticalShift Timing: 2 pm to 11 pmLocations: Pune/Bangalore/LucknowKey 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.



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