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JD For Clinical Study design_MBBS_Hyderabad

JD For Clinical Study design_MBBS_Hyderabad

Randstad

1 - 4 years

6 - 13 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

Literature Search Clinical Development Clinical Trials Protocol Writing medical reviwer

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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JD For Clinical Study design_MBBS_Hyderabad