Medical Writer Job at Sun Pharma, Mumbai. Apply Now
Looking for a career in medical writing? Sun Pharma, a global pharmaceutical leader, is hiring a Medical Writer in Mumbai. Join us to create impactful clinical documents, research publications, and regulatory reports while collaborating with industry experts. Apply today!
Sun Pharma Laboratories Ltd, a leading pharmaceutical company, is committed to providing high-quality healthcare solutions to improve patients’ lives worldwide.
Job Posting: Medical Writer
Title: Medical Writer
Date: Feb 20, 2025
Location: Sun House – Corporate Office
Company: Sun Pharma Laboratories Ltd
Tasks and Responsibilities as Medical Writer Job Role
- Develop and update process documents, SOPs, and trackers for the 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
- In this Medical Writer Job role, you will 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 the 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 in medical writing for complex publications (e.g., Meta-analysis, consensus, guidelines) with successful outcomes 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 types of publications
Job Location: Sun House, Mumbai
Keywords: Medical Writer, Sun Pharma, Pharmaceuticals, Clinical Trial, Healthcare, Medical Writing
