Job Title: Medical Writer (Clinical Trials)
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Sun House, Mumbai, India
Date Posted: Oct 24, 2025
Company Overview:
At Sun Pharma, employees are encouraged to “Create your own sunshine” by fostering growth, self-drive, collaboration, and continuous improvement. The company emphasizes professional development, teamwork, and a supportive work culture.
Role Summary:
As a Medical Writer, you will prepare, review, and edit clinical trial documents, publications, and related materials to ensure accuracy, compliance, and alignment with regulatory and publication guidelines. You will collaborate with internal and external stakeholders to support clinical research and medical affairs activities.
Key Responsibilities:
Develop and update 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), and patient diaries.
Prepare, review, and edit Clinical Study Reports (CSR), executive summaries, and study-specific logs.
Ensure all study documents comply with ICH-GCP, CDSCO, and applicable regulatory guidelines.
Conduct quality checks (QC) of protocols, CRFs, ICDs, CSRs, and related documents.
Lead review cycles of documents with respective stakeholders for timely completion.
Finalize publication plans for manuscripts in coordination with medical affairs personnel.
Prepare and review manuscripts, including original research, review articles, meta-analyses, consensus/expert opinions, abstracts, posters, in alignment with ICMJE, GPP3, and other relevant guidelines.
Collaborate with internal stakeholders: clinical research, medical affairs, business, regulatory, legal, compliance, and project-specific teams.
Coordinate with external stakeholders: investigators, KOL authors, biostatisticians, data management teams, and medical association office bearers.
Manage medical writing vendors, ensuring compliance with Sun Pharma policies.
Ensure execution of MSAs, project contracts, and invoice management.
Qualifications:
Required: MBBS
Experience:
3–5 years in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies.
Additional Skills & Competencies:
Formal training in Medical Writing (preferred).
Well-versed with ICMJE, GPP3, STROBE, CONSORT, STARD, CARE, PRISMA guidelines.
Experience in complex publications (meta-analysis, consensus, guidelines) and publications in indexed journals.
Training in clinical trial methodologies, research design, ICH-GCP, and publication guidelines.
Knowledge of Drugs and Cosmetic Act regulations for clinical trials and new drug approvals.
Strong academic record and knowledge of research methodologies and publication processes.
Additional Information:
Sun Pharma provides robust benefits, professional growth opportunities, and a supportive work environment.
Job description may evolve; employees may be assigned comparable duties commensurate with experience.
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