Medical Writer Job in Mumbai | Sun Pharma Laboratories Ltd | Apply Today!
Join Sun Pharma Laboratories Ltd, a global leader in pharmaceuticals, as a Medical Writer at our Corporate Office in Mumbai. In this role, you will be responsible for developing clinical documents, regulatory submissions, and publications, ensuring compliance with ICH-GCP, CDSCO, and international guidelines. If you have 3-5 years of experience in medical writing, expertise in clinical trials and regulatory affairs, and a pharmacy or life sciences background, apply today!
About the Company:
Sun Pharma Laboratories Ltd is one of the world’s leading pharmaceutical companies, dedicated to improving global healthcare by developing high-quality, affordable medicines. Founded in 1983, Sun Pharma has grown into India’s largest pharmaceutical company and ranks among the top global generic drug manufacturers. With a presence in over 100 countries, Sun Pharma specializes in branded and generic formulations, active pharmaceutical ingredients (APIs), and specialty medicines across multiple therapeutic areas, including neurology, dermatology, oncology, cardiology, and psychiatry. The company’s focus on research-driven innovation has led to groundbreaking developments in complex generics, biosimilars, and novel drug delivery systems.
Job Description
Title: Medical Writer
Location: Sun House – Corporate Office, Mumbai
Your Tasks and Responsibilities for Medical Writer Job in Mumbai:
- 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 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, following Sun Pharma policies and procedures
- Ensure execution of MSAs, project contracts, and invoice management
Who Can Apply for Medical Writer Job in Mumbai:
- 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 a 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 about clinical trials and new drug approvals
- Strong academic record with knowledge of research methodologies & publication processes for different types of publications
Keywords: Medical Writer, Sun Pharma Laboratories, Mumbai, Clinical Trials, Publications, Pharmaceutical, Regulatory Guidelines, Vendor Management
