Sun Pharma Medical Writer Job For Pharma, Apply Online
Company: Sun Pharma Laboratories Ltd.
Date: March 21, 2025
Location: Sun House – Corporate Office, Mumbai
Job Title: Medical Writer
Your Tasks and Responsibilities of a Medical Writer:
- Develop and update process documents, Standard Operating Procedures (SOPs), and trackers 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 (if applicable).
- Prepare, review, and edit Clinical Study Reports (CSR), executive summaries, and study-specific logs.
- Ensure all study documents (protocol, ICD, CRF, patient diaries, and CSRs) are prepared in alignment with ICH-GCP, CDSCO guidelines, and all applicable regulatory guidelines
- Conduct quality checks (QC) of protocols, protocol amendments, CRF, ICD, CSR, and other relevant documents.
- Lead review cycles of documents with respective stakeholders for timely completion.
- Finalize publication plans for each manuscript in coordination with medical affairs personnel.
- Prepare and review manuscripts, including original research articles, review articles, meta-analyses, consensus/expert opinions, abstracts, posters, and other relevant documents, in alignment with IJCME, GPP3, and other relevant guidelines.
- Work cohesively with internal stakeholders, including the Clinical research team, Medical Affairs team, business team, regulatory affairs, legal team, compliance team, and project-specific functions.
- Coordinate with external stakeholders, including investigators, Key Opinion Leader (KOL) authors, biostatisticians, data management teams, and medical association office bearers.
- Vendor management for medical writing vendors, in accordance with Sun Pharma policies and procedures.
- Ensure execution of Master Service Agreements (MSAs), project contracts, and invoice management.
Who You Are:
- 3-5 years of experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies.
- Preferably a Pharmacy post-graduate/graduate.
- Formal training in Medical Writing is a valuable addition.
- Well-versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines, and the PRISMA statement.
- Experience in medical writing for complex publications (e.g., meta-analysis, consensus, guidelines) with successful outcomes is an added advantage.
- Experience in publications in indexed journals.
- Training in clinical trial methodologies, research design, and ICH-GCP & publication guidelines.
- Relevant knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals.
- Strong academic record with knowledge of research methodologies and publication processes for different types of publications.
Job Location:
- Sun House, Mumbai.
Keywords: Medical Writer, SUN Pharma, Job Posting, Clinical Trial, Publications, Pharma, Medical Writer, Pharma Job
