Medical Writer
3 days ago
**Title**:Medical Writer**:
- Date: Feb 20, 2025
- Location: Sun House - Corporate Office
- Company: Sun Pharma Laboratories Ltd
**YOUR TASKS AND RESPONSIBILITIES**:
- Develop and update process documents, SOPs and trackers for Medical Writing Function
- Prepare, review and edit clinical trial protocols, investigator’s brochure (IB), Case Report Form (CRF), Informed Consent Document (ICD) and Patient diaries (if applicable)
- Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs
- Ensure all study documents like protocol, ICD, CRF, patient diaries & CSRs are prepared in alignment with ICH-GCP, CDSCO guidelines and all applicable regulatory guidelines
- Conduct quality check (QC) of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents
- Lead review cycles of documents with respective stakeholders for timely completion
- Finalize publication plan for each manuscript in coordination with respective medical affairs personnel
- Prepare and review manuscripts - original research articles, review articles, meta-analyses, consensus / expert opinion, abstracts, posters and other relevant documents, in alignment with IJCME, GPP3 and any other relevant guidelines
- Work cohesively with internal stakeholders including Clinical research team, Medical Affairs team, business team, regulatory affairs, legal team, compliance team and project specific other functions
- Strong coordination with external stakeholders including investigators, Key Opinion Leader (KOL) authors, Biostatisticians, Data management team & medical association office bearers
- Vendor management for Medical writing vendors, in accordance with Sun Pharma policies and procedures.
- Ensure execution of MSAs, project contracts, and invoice management
**WHO YOU ARE**:
- 3-5 years’ experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies
- Preferably Pharmacy post-graduate /graduate
- Formal training in Medical Writing will be value add
- Well versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines and PRISMA statement
- Experience of medical writing for complex publications (e.g. Meta-analysis, consensus, guidelines) with successful outcome will be of added advantage
- Experience in publications in indexed journals
- Training in clinical trial methodologies, research design and ICH - GCP & publication guidelines
- Relevant knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
- Strong academic record with knowledge of research methodologies & publication processes for different type of publications
**Job Location**:Sun House, Mumbai
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