Clinical Trial Medical Writer
4 hours ago
Are you a skilled medical writer looking for a challenging role in a dynamic environment? Sun Pharma is seeking a Clinical Trial Medical Writer to join our team
Key Responsibilities:
- Prepare high-quality clinical trial protocols, investigator brochures, and regulatory documents.
- Conduct literature searches and write clinical journal manuscripts, abstracts, and study articles for publication.
- Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs.
- Coordinate with data management teams to ensure timely review of data extracts and data cleaning activities.
- Work closely with biostatisticians to engage early with the study team for sample size certificates, review of statistical analysis plans, and narrative and discussion planning for relevant documents.
Requirements:
- B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/life sciences educational background.
- Excellent medical writing skills and well-versed with different guidelines such as IMRAD, CONSORT, and relevant publication guidelines.
- Thorough knowledge of GCP guidelines, ICMR guidelines, and Drugs and Cosmetic Act regulations pertaining to clinical trials and other regulatory guidelines like FDA.
Competency Requirements:
- Strong medical knowledge of different therapeutic areas.
- Sound functional knowledge of clinical research and medical writing activities.
- Collaboration and teaming with ability to work in a matrix environment.
- Strategic thinking & sound analytical skills.
Working Conditions:
- The role is based at Sun House Mumbai. Occasional travel related to official work may be required.
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