Key Responsibilities
- Conduct medical review of study related documents
- Prepare high quality medical rationale documents for agency submission
- Periodic Safety review
- Medical monitoring
- Develop clinical rationale for new products.
Competencies and exposure to succeed in the role.
- Previous experience in medical review of clinical study documents (trial and BA/BE).
- Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA.
- Familiarity with medical coding dictionaries (e.g., MedDRA) and safety reporting
- Strong attention to detail and ability to work with complex medical data.
- Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.