Medical Writer – Clinical Trials
Company: Sun Pharmaceutical Laboratories Ltd
Business Unit: Clinical Research
Location: Sun House – Corporate Office, Mumbai, India
Job Type: Full-Time
Posted Date: January 19, 2026
Experience Required: 3–5 Years
Job Overview
Sun Pharmaceutical Laboratories Ltd is hiring an experienced Medical Writer – Clinical Trials to support its Clinical Research function at its corporate office in Mumbai. This role is ideal for medical professionals with strong expertise in clinical trial documentation, regulatory-compliant medical writing, and scientific publications.
The Medical Writer will be responsible for developing high-quality clinical and scientific documents aligned with global regulatory standards, ensuring accuracy, consistency, and compliance across interventional and non-interventional studies.
Key Responsibilities
Develop, update, and maintain Standard Operating Procedures (SOPs), process documents, templates, and trackers for the Medical Writing function
Prepare, review, and edit clinical trial documents including protocols, Investigator’s Brochure (IB), Case Report Forms (CRF), Informed Consent Documents (ICD), and patient diaries
Author, review, and finalize Clinical Study Reports (CSR), executive summaries, and study-specific logs
Ensure all clinical documents comply with ICH-GCP, CDSCO, and applicable global regulatory guidelines
Perform quality control (QC) checks on protocols, amendments, CRFs, ICDs, CSRs, and related documents
Lead internal and external document review cycles to ensure timely completion and version control
Develop and execute publication plans in coordination with Medical Affairs teams
Prepare and review manuscripts including original research articles, review articles, meta-analyses, consensus papers, abstracts, posters, and scientific presentations
Ensure publication compliance with ICMJE, GPP3, CONSORT, STROBE, STARD, CARE, and PRISMA guidelines
Collaborate closely with internal stakeholders including Clinical Research, Medical Affairs, Regulatory Affairs, Legal, Compliance, Business teams, and project-specific functions
Coordinate with external stakeholders such as investigators, Key Opinion Leaders (KOLs), biostatisticians, data management teams, and medical associations
Manage medical writing vendors, including execution of MSAs, project contracts, and invoice management in accordance with company policies
Educational Qualification
MBBS (mandatory)
Experience Requirements
3 to 5 years of relevant experience in Medical Writing within a Pharma, CRO, or Biotech organization
Hands-on experience in medical writing for interventional and non-interventional clinical studies
Proven experience in preparing regulatory-compliant clinical trial and publication documents
Required Skills and Competencies
Formal training in Medical Writing is an added advantage
Strong knowledge of ICH-GCP, clinical trial methodologies, and research design
In-depth understanding of global publication guidelines including ICMJE, GPP3, CONSORT, STROBE, PRISMA, CARE, and STARD
Experience in publishing scientific manuscripts in indexed journals
Expertise in complex medical writing projects such as meta-analyses, consensus statements, and clinical guidelines
Working knowledge of Drugs and Cosmetics Act regulations related to clinical trials and new drug approvals in India
Excellent scientific writing, editing, and communication skills
Strong attention to detail, project management ability, and stakeholder coordination skills
Why Join Sun Pharma?
Sun Pharma offers a dynamic and collaborative work environment where professionals are empowered to grow, innovate, and make a meaningful impact on global healthcare. Employees benefit from structured career development, exposure to high-impact research, and opportunities to work on scientifically significant projects across therapeutic areas.
Disclaimer
This job description outlines the general nature and level of responsibilities associated with this role. It is not intended to be an exhaustive list of duties, responsibilities, or qualifications. Sun Pharmaceutical Laboratories Ltd reserves the right to modify job responsibilities as business requirements evolve.
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