location_onAhmedabad, Gujarat, India
watch_later Posted: Apr 04, 2025
Job Description
Key Responsibilities:
Essential Requirements:
- To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives
- Act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- Reporting of technical complaints / adverse events / special case scenarios
- Distribution of marketing samples (where applicable) Timely preparation of publications to satisfy regulatory requirements for publication of clinical trial results, to increase customer awareness of company products, and to support marketing activities.
Essential Requirements:
- Minimum: Life-science degree or equivalent B.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experience, Desired – Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience
- Excellent written and oral English.
- Ability to work, prioritize, and drive projects independently.
- Ability to handle multiple projects and partners.
