Medical Writer
Date: February 20, 2025
Company: Sun Pharma Laboratories Ltd
Location: Sun House – Corporate Office, Mumbai
Industry: Pharmaceuticals / Clinical Research
Job Type: Full-time
Your Tasks and Responsibilities:
Medical & Scientific Documentation:
Develop and update process documents, SOPs, and trackers for the Medical Writing function.
Prepare, review, and edit key clinical documents, including:
Clinical Trial Protocols
Investigator’s Brochure (IB)
Case Report Forms (CRF)
Informed Consent Documents (ICD)
Patient Diaries (if applicable)
Clinical Study Reports (CSR) and executive summaries
Ensure all study documents comply with ICH-GCP, CDSCO, and other relevant regulatory guidelines.
Conduct quality checks (QC) of study documents like protocols, amendments, CRF, ICD, CSR, etc.
Lead review cycles of documents with stakeholders to ensure timely completion.
Scientific Publications & Medical Affairs:
Finalize publication plans for manuscripts in collaboration with the Medical Affairs team.
Prepare and review:
Original research articles
Review articles
Meta-analyses
Consensus/expert opinions
Abstracts & posters
Ensure alignment with IJCME, GPP3, STROBE, CONSORT, STARD, CARE, and PRISMA guidelines.
Stakeholder & Vendor Management:
Work closely with internal stakeholders:
Clinical Research Team
Medical Affairs Team
Business Team
Regulatory Affairs
Legal & Compliance Teams
Maintain strong coordination with external stakeholders, including:
Investigators & Key Opinion Leaders (KOLs)
Biostatisticians & Data Management Team
Medical Associations
Manage medical writing vendors, ensuring compliance with Sun Pharma policies.
Oversee execution of MSAs, project contracts, and invoice management.
Who You Are:
Experience:
3-5 years in CRO/Pharma/Biotech with experience in Medical Writing for interventional & non-interventional studies.
Experience in medical writing for complex publications (e.g., meta-analysis, consensus, guidelines) with successful outcomes is preferred.
Experience in publishing in indexed journals is a plus.
Education:
Preferably a Pharmacy Postgraduate/Graduate.
Formal training in Medical Writing is an added advantage.
Knowledge & Skills:
Strong understanding of ICH-GCP, Drugs and Cosmetic Act, and clinical trial regulations.
Proficiency in research methodologies & publication processes.
Familiarity with clinical trial methodologies, research design, and publication guidelines.
Job Location:
Sun House, Mumbai
Interested candidates can apply accordingly.
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