Job Description
Sun Pharma is hiring a Medical Writer for its Mumbai location. This role is part of the MACR business unit and involves medical writing activities for clinical study documents, publications, manuscripts, and related regulatory documentation.
The position is suitable for candidates with experience in medical writing within a CRO, pharma, or biotech organization, especially for interventional and non-interventional studies. The role is majority office based and will involve an average 8 to 10 days of travel outside Mumbai.
Job Details
| Company | Sun Pharma |
| Position | Medical Writer |
| Business Unit | MACR |
| Department | Regulatory Affairs |
| Location | Mumbai, IN |
| Work Mode | On-site |
| Experience | 3-5 Years |
Key Responsibilities
- Develop and update process documents, SOPs and trackers for the Medical Writing function.
- Prepare, review and edit clinical trial protocols, Investigator’s Brochure (IB), Case Report Form (CRF), Informed Consent Document (ICD) and patient diaries, if applicable.
- Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs.
- Ensure study documents such as protocol, ICD, CRF, patient diaries and CSRs are prepared in alignment with ICH-GCP, CDSCO guidelines and applicable regulatory guidelines.
- Conduct quality check of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents.
- Lead document review cycles with respective stakeholders for timely completion.
- Finalize publication plans for each manuscript in coordination with respective medical affairs personnel.
- Prepare and review manuscripts including original research articles, review articles, meta-analyses, consensus or expert opinion documents, abstracts, posters and other relevant documents in alignment with IJCME, GPP3 and other relevant guidelines.
- Work with internal stakeholders including clinical research, medical affairs, business, regulatory affairs, legal, compliance and project-specific teams.
- Coordinate with external stakeholders including investigators, Key Opinion Leader authors, biostatisticians, data management teams and medical association office bearers.
- Manage medical writing vendors in accordance with Sun Pharma policies and procedures.
- Ensure execution of MSAs, project contracts and invoice management.
- Work on clinical study protocol, clinical study report, informed consent document, abstract preparation, manuscript reviewing and writing, publications in indexed medical journals, research articles, review articles, meta-analysis, and overall project and budget management.
Qualification
- Preferably Pharmacy post-graduate / graduate.
- Bachelor’s or Master’s degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate in Clinical Research.
- Formal training in Medical Writing will be value add.
- Well versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines and PRISMA statement.
- Training in clinical trial methodologies, research design and ICH – GCP and 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 type of publications.
- Experience of medical writing for complex publications, such as meta-analysis, consensus and guidelines, with successful outcome will be of added advantage.
- Experience in publications in indexed journals.
Experience
Candidates should have 3-5 years’ experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies.
How to Apply
Interested candidates can apply online through the official Sun Pharma careers link given below.
