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AGM/DGM – Clinical Trials
1 month ago
About the Company
It is a leading pharmaceutical organization with a strong global presence and a reputation for scientific excellence, regulatory compliance, and high-quality formulations. The company has a robust R&D infrastructure and is deeply committed to innovation, affordability, and advancing healthcare through rigorous clinical research and development.
Role Overview
The role involves leading the development and finalization of key clinical trial documents, ensuring scientific accuracy, regulatory compliance, and clarity. The ideal candidate will work closely with cross-functional teams to support the full lifecycle of clinical documentation, from protocol development to submission-ready deliverables.
Key Responsibilities
- Lead the drafting and review of clinical trial protocols in collaboration with medical, regulatory, and operational teams.
- Prepare high-quality clinical documents including:
- Clinical Study Reports (CSRs)
- Investigator's Brochures (IBs)
- Informed Consent Forms (ICFs)
- Subject-facing materials and study training documents
- Ensure adherence to ICH-GCP, CDSCO, and internal quality standards in all clinical writing deliverables.
- Support ethics committee and regulatory authority submissions with required documentation.
- Act as a point of contact for cross-functional teams on clinical documentation matters.
- Contribute to ongoing process improvements and standardization efforts within the clinical documentation function.
Key Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related discipline.
- 10–18 years of experience in clinical trials, clinical documentation, or medical writing in a pharmaceutical or CRO setting.
- Strong understanding of clinical research regulations and documentation requirements.
- Demonstrated ability to independently draft and manage clinical trial documents.
- Excellent communication, collaboration, and project management skills.
- Familiarity with global regulatory submission standards and expectations.
