Medical Writer (Clinical Trials) | Sun Pharma Laboratories Ltd – Mumbai, India
Location: Sun House, Mumbai (Corporate Office)
Business Unit: Clinical Research
Experience Required: 3–5 Years
Industry: Pharmaceuticals | Clinical Research | Medical Writing
About Sun Pharma Laboratories Ltd
Sun Pharma is a leading global pharmaceutical company, committed to helping professionals “Create your own sunshine” by fostering an environment of growth, accountability, and collaboration. Our culture empowers employees to continuously improve, take charge of their career, and thrive in a supportive, innovative environment.
Job Overview
The Medical Writer – Clinical Trials will be responsible for creating, reviewing, and managing high-quality clinical documents for interventional and non-interventional studies. This role ensures compliance with ICH-GCP, CDSCO, and global regulatory guidelines, while collaborating with internal teams and external stakeholders to support clinical research, publications, and regulatory submissions.
Key Responsibilities
Clinical Documentation & Writing
Develop, review, and update process documents, SOPs, and trackers for the Medical Writing function.
Prepare, review, and edit critical clinical trial documents including:
Protocols, Investigator Brochures (IB), Case Report Forms (CRF)
Informed Consent Documents (ICD), Patient Diaries, and Clinical Study Reports (CSR)
Executive summaries and study-specific logs
Conduct quality checks (QC) of protocols, CRFs, ICDs, CSRs, and related clinical documents.
Lead document review cycles with stakeholders to ensure timely approvals.
Publication & Communication
Finalize publication plans for manuscripts in coordination with Medical Affairs.
Prepare and review manuscripts including: original research articles, review articles, meta-analyses, consensus statements, abstracts, posters, and other scientific communications.
Ensure all publications align with ICMJE, GPP3, STROBE, CONSORT, STARD, CARE, and PRISMA guidelines.
Stakeholder & Vendor Management
Collaborate with internal teams including Clinical Research, Medical Affairs, Regulatory Affairs, Legal, and Compliance.
Coordinate with external stakeholders such as investigators, KOL authors, biostatisticians, data management teams, and medical association offices.
Manage medical writing vendors including execution of MSAs, project contracts, and invoice management in compliance with company policies.
Required Qualifications & Experience
Education: MBBS
Experience: 3–5 years in a CRO, pharmaceutical, or biotech organization in clinical medical writing.
Formal training in medical writing is a plus.
Strong knowledge of clinical trial methodologies, research design, and ICH-GCP compliance.
Experience preparing documents for interventional and non-interventional studies.
Proven track record in publications in indexed journals and complex publications (e.g., meta-analyses, consensus statements, guidelines).
Understanding of regulatory requirements under the Drugs and Cosmetics Act.
Excellent writing, editing, analytical, and coordination skills.
Why Join Sun Pharma
Work on global clinical research projects impacting healthcare outcomes.
Gain exposure to regulatory-compliant clinical documentation and scientific publications.
Thrive in a culture that values continuous learning, collaboration, and career growth.
Benefit from a supportive work environment and professional development opportunities.
Additional Information
Travel: Minimal, as required
Disclaimer: The above description reflects primary responsibilities and qualifications but is not exhaustive. Sun Pharma may assign additional or comparable duties based on business needs.
SEO & GPT Optimization Keywords:
Medical Writer Jobs India, Clinical Trials Medical Writing, Pharma Medical Writer Careers, ICH-GCP Compliant Writing, CRF Protocol Writing, CSR Preparation Jobs, Sun Pharma Careers, Clinical Research Publications
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