As a Medical Writer at Sun Pharma Laboratories Ltd, you will be responsible for creating high-quality clinical protocols, investigator brochures, regulatory documents, clinical study reports, and publications. You will coordinate with vendors for outsourced activities, assist with scale procurement, and ensure compliance with medical writing SOPs and regulatory guidelines.
Key Responsibilities:
- Prepare and review protocols, study reports, and regulatory documents.
- Draft manuscripts, posters, and abstracts for publication and conferences.
- Collaborate with clinical, regulatory, and operational teams for study synopsis reviews.
- Ensure compliance with ICH GCP, Indian, and global regulatory requirements.
- Conduct literature searches to support clinical trial documentation.
- Coordinate with biostatisticians, data management teams, and vendors to ensure timely data review and database lock.
- Register clinical trials on registries (e.g., CTRI).
- Mentor junior medical writers on complex projects.
Required Experience:
- Educational Background: B. Pharma, M.Sc., M.Pharma, PhD, BAMS, BHMS, or Life Sciences.
- Relevant Skills: Medical writing experience is preferred. Strong understanding of clinical research, GCP/GDP regulations, IMRAD, CONSORT, and other publication guidelines. Familiarity with statistical tools and data coding systems like MedDRA and WHO-DD.
Competencies:
- Strong medical knowledge and writing skills.
- Excellent communication and interpersonal skills.
- Strategic thinking, analytical abilities, and result-driven mindset.
Working Conditions:
Based at Sun House in Mumbai with occasional travel for official work.
Keywords:
Medical Writer Mumbai Jobs, Sun Pharma Careers, Sun Pharma Jobs.
