Principal Clinical and Medical Affairs Specialist
Contract: 3-months
Start date: November 10th
Location: Remote
Responsible for overseeing all operational aspects of clinical trial setup and management (both pre- and post-market) and for providing cross-functional medical review support to ensure regulatory submission package readiness.
Key Responsibilities
- Manage global clinical studies, ensuring adherence to timelines and budgets.
- Oversee and manage external vendors, including CROs.
- Prepare documentation for FDA supplements and subsequent interactive reviews, including but not limited to CSR, DFU, SSED, and clinical narratives.
- Serve as the Medical Advisor for the company’s Complaints and Vigilance team.
- Review MDR-related documents such as CERs, CEPs, SOTAs, and PMCF plans for both U.S. and European markets.
- Serve as the Medical Advisor for the U.S. market launch of the company’s product portfolio.
Qualifications
- Strong background in ophthalmology (MD preferred).
- Minimum 3 years of experience in clinical research, clinical operations, or a related scientific or medical field, with experience managing external vendors.
- Solid understanding of the operational processes involved in conducting clinical studies for medical devices and/or pharmaceuticals.
- In-depth knowledge of clinical trial regulations and guidelines (GCP, FDA, ICH, ISO, ANSI, etc.).
- Fluent in English.
Interested? Apply here or send your CV to m.spinetta@panda-int.com