Company: BIO SRL
Location: Mira Road (Mumbai)
Designation: Medical Writer
Department: Clinical
Qualification: B. Pharma/M. Pharma
Experience: 2 to 5 Years (CRO Experienced)
Principal Duties and Responsibilities:
1. Preparation of study protocol, ICF, EC and other regulatory documents.
2. Design and review protocols for studies by Good Clinical Practice (GCP) and applicable national and international regulatory guidelines for conducting studies.
3. Preparation and submission of the final version of the protocol.
4. Clinical Study Report after completion of the study.
5. Raise change control documentation for clinical SOP, instrument, and equipment.
6. Provide responses to QA, sponsor, and regulatory audit observations with CAPA.
7. Perform additional activities delegated by the Head of the department/Investigator/Manager.
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