Medical Writer

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