Clinical Trial Job at Sun Pharma | Medical Writer Role in Mumbai
Looking for a rewarding clinical trial job with strong growth opportunities? This Medical Writer position at Sun Pharma offers an excellent pathway for professionals seeking to advance in clinical research while exploring promising Sun Pharma careers. Based at the Sun House corporate office, this role also appeals to candidates searching for high-quality jobs in Mumbai within the pharmaceutical sector.
Job Details:
- Title: Medical Writer (Clinical Trials)
- Location: Sun House – Corporate Office
- Company: Sun Pharma Laboratories Ltd
- Business Unit: Clinical Research
About the Company
Sun Pharma Laboratories Ltd is a globally recognized pharmaceutical leader offering diverse Sun Pharma careers for professionals aiming to contribute to high-quality research and innovation. The company fosters a culture of ownership, collaboration, and continuous learning, empowering employees to “Create your own sunshine” as they grow within the organization. With its strong presence and attractive jobs in Mumbai, Sun Pharma remains a preferred employer in the life sciences industry.
Qualifications & Requirements
Educational Qualification
Experience
- 3–5 years of experience in a CRO/Pharma/Biotech environment in medical writing for interventional and non-interventional studies.
- Experience in complex publications (meta-analyses, guidelines, consensus documents) and indexed journal publications is advantageous.
Clinical Trial Job Description
This clinical trial job offers an opportunity to work closely with cross-functional teams to create, review, and manage clinical research documents for various studies. As part of Sun Pharma’s Clinical Research Business Unit, the Medical Writer contributes to essential scientific communication and document compliance, supporting the company’s commitment to research excellence and strengthening the pipeline of Sun Pharma careers.
Key Responsibilities:
- Develop and update SOPs, trackers, and process documents for the Medical Writing function.
- Prepare, review, and edit clinical trial protocols, investigator’s brochures (IB), Case Report Forms (CRF), Informed Consent Documents (ICD), and patient diaries.
- Prepare, review, and edit Clinical Study Reports (CSR), executive summaries, and study-specific logs.
- Ensure study documents (protocols, ICD, CRF, patient diaries, CSRs) align with ICH-GCP, CDSCO, and all regulatory guidelines.
- Conduct QC for protocols, amendments, CRFs, ICDs, CSRs, and related documentation.
- Lead document review cycles with relevant stakeholders to ensure timely completion.
- Finalize publication plans in coordination with Medical Affairs teams.
- Prepare and review manuscripts, including research articles, reviews, meta-analyses, expert opinions, abstracts, posters, etc., aligned with IJCME, GPP3, and other guidelines.
- Collaborate with clinical research teams, Medical Affairs, business teams, Regulatory Affairs, Legal, Compliance, and other project-specific functions.
- Coordinate with external stakeholders such as investigators, KOLs, biostatisticians, data management teams, and medical associations.
- Manage medical writing vendors according to Sun Pharma policies.
- Oversee MSAs, project contracts, and invoice management.
Clinical Trial Job – Additional Skills
- Training in Medical Writing adds value.
- Familiarity with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines, and the PRISMA statement.
- Knowledge of clinical trial methodologies, ICH-GCP, publication guidelines, and research design.
- Understanding of the Drugs and Cosmetics Act regulations for clinical trials and new drug approvals.
- Strong academic background with knowledge of research methodologies and publication processes.
