Medical Writer – Clinical Trials
Company: Sun Pharma Laboratories Ltd
Location: Sun House, Mumbai, India
Experience Required: 3–5 Years
Date Posted: 21st December 2025
Business Unit: Clinical Research
Job Type: Full-Time, Permanent
About Sun Pharma
At Sun Pharma, we empower professionals to “Create your own sunshine” by fostering a culture of continuous growth, self-drive, and collaboration. Our environment supports your career journey, allowing you to take charge, innovate, and thrive in a high-performing, impactful organization.
Key Responsibilities
Medical Writing & Documentation
Develop, update, and maintain process documents, SOPs, and trackers for the Medical Writing function.
Prepare, review, and edit clinical trial documents, including protocols, investigator 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 all study documents are compliant with ICH-GCP, CDSCO guidelines, and other applicable regulatory requirements.
Conduct quality checks (QC) of protocols, protocol amendments, CRFs, ICDs, CSRs, and related documents.
Lead review cycles with internal stakeholders to ensure timely document completion.
Publications & External Collaboration
Finalize publication plans in coordination with medical affairs personnel.
Prepare and review manuscripts, including original research articles, review articles, meta-analyses, consensus statements, abstracts, posters, and other scientific communications.
Ensure alignment with ICMJE, GPP3, STROBE, CONSORT, STARD, CARE guidelines, and PRISMA statement.
Collaborate effectively with internal teams, including Clinical Research, Medical Affairs, Regulatory Affairs, Legal, Compliance, and project-specific stakeholders.
Coordinate with external stakeholders such as investigators, Key Opinion Leaders (KOLs), biostatisticians, data management teams, and medical association offices.
Vendor & Project Management
Manage medical writing vendors, ensuring compliance with Sun Pharma policies and procedures.
Execute Master Service Agreements (MSAs), project contracts, and invoice management.
Job Requirements
Education:
MBBS or equivalent degree.
Experience:
3–5 years of Medical Writing experience in a CRO, pharmaceutical, or biotech organization for interventional and non-interventional studies.
Additional Skills & Competencies:
Formal training in Medical Writing is a plus.
Well-versed with ICMJE, GPP3, STROBE, CONSORT, STARD, CARE, and PRISMA guidelines.
Experience with complex publications such as meta-analyses, consensus documents, and guidelines.
Proven track record of publications in indexed journals.
Knowledge of clinical trial methodologies, research design, and ICH-GCP principles.
Understanding of Drugs & Cosmetics Act regulations relevant to clinical trials and new drug approvals.
Strong academic and research background with expertise in scientific writing and publication processes.
Why Join Sun Pharma?
Opportunity to work on high-impact clinical trials and scientific publications.
Exposure to cutting-edge clinical research and regulatory practices.
Collaborative and supportive environment fostering personal and professional growth.
Direct contribution to advancing patient care and scientific knowledge globally.
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