Job Title: Medical Writer – Clinical Trials
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Sun House, Mumbai, India
Posted Date: December 21, 2025
Company Overview:
Sun Pharma is committed to helping employees “Create Your Own Sunshine” by fostering a growth-oriented environment where professionals take charge of their careers, thrive collaboratively, and continually develop their skills. With a global presence in the pharmaceutical and biotech sector, Sun Pharma encourages innovation, excellence, and meaningful contributions to healthcare.
Position Overview:
We are seeking an experienced Medical Writer with 3–5 years of experience in clinical trial documentation and scientific publications. The role involves preparing, reviewing, and editing regulatory and clinical documents, ensuring compliance with ICH-GCP, CDSCO, and global publication standards. The ideal candidate will have strong expertise in medical writing for interventional and non-interventional studies, including manuscripts, meta-analyses, and clinical study reports.
Key Responsibilities:
Develop and maintain process documents, SOPs, and trackers for the Medical Writing function.
Prepare, review, and edit clinical trial protocols, Investigator Brochures (IB), Case Report Forms (CRF), Informed Consent Documents (ICD), patient diaries, and other study-specific documents.
Prepare, review, and edit Clinical Study Reports (CSR), executive summaries, and study-specific logs.
Ensure all study documents are compliant with ICH-GCP, CDSCO guidelines, and applicable regulatory requirements.
Conduct quality checks (QC) of protocols, CRFs, ICDs, CSRs, and related documents.
Lead review cycles with internal stakeholders for timely completion of documentation.
Finalize publication plans for manuscripts in collaboration with Medical Affairs personnel.
Prepare and review manuscripts for original research, review articles, meta-analyses, consensus/expert opinions, abstracts, posters, and other scientific documents following IJCME, GPP3, and relevant guidelines.
Collaborate with internal stakeholders including Clinical Research, Medical Affairs, Regulatory Affairs, Legal, Compliance, and project-specific teams.
Coordinate with external stakeholders such as investigators, Key Opinion Leaders (KOLs), biostatisticians, data management teams, and medical associations.
Manage vendors for medical writing services according to Sun Pharma policies, including execution of MSAs, project contracts, and invoice management.
Educational Requirements:
MBBS (Mandatory)
Experience Requirements:
3–5 years of experience in medical writing within a CRO, pharmaceutical, or biotech organization for interventional and non-interventional studies.
Additional Skills & Knowledge:
Formal training in Medical Writing is an advantage.
Expertise with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines, and PRISMA statement.
Experience in complex publications such as meta-analyses, consensus papers, and guidelines.
Prior publications in indexed journals are preferred.
Knowledge of clinical trial methodology, research design, and ICH-GCP standards.
Understanding of Drugs and Cosmetics Act regulations related to clinical trials and new drug approvals.
Strong academic record and familiarity with scientific research and publication processes.
Why Join Sun Pharma:
At Sun Pharma, your growth and success are priorities. We provide competitive benefits, robust professional development opportunities, and a culture of collaboration and innovation. Join us to contribute to impactful medical research and make meaningful contributions to patient care worldwide.
Apply Today:
If you are a skilled Medical Writer with experience in clinical trials and scientific publications, apply now to join Sun Pharma at Sun House, Mumbai.
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