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Medical Writer

3-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.