JD For Clinical Study design_MBBS_Hyderabad Randstad

1.0 - 4.0 years

6 - 13 Lacs

Hyderabad

Work from Office

Role & responsibilities : 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. Preferred candidate profile

Posted 1 month ago

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