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Oncology Access and Compliance Specialist
2 months ago
Key Responsibilities:
- Collaborate with internal stakeholders to provide operational leadership for GSK oncology expanded access/compassionate programs, including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor setup and management, safety reporting, and other related activities in accordance with GSK Policies and SOPs.
- Oversee the management of vendors associated with access programs, ensuring compliance with regulatory requirements.
- Establish operations to ensure rapid response to requests from physicians regarding patient access to EAP/CU programs, prioritizing patient needs and safety.
- Provide regular status updates on program utilization to internal stakeholders, highlighting key performance indicators and areas for improvement.
- Offer operational input and assistance when required, leveraging expertise to drive program success.
- Develop and maintain strong relationships with all stakeholders, including Global Medical Affairs colleagues, LOCs, physicians, program managers, regulatory, and safety teams, fostering a collaborative environment.
Basic Qualifications:
We are seeking professionals with these required skills to achieve our goals:
- Bachelor's degree in a life science-related field.
- Four or more years of demonstrable, varied, and progressive experience in a professional scientific or clinical role, either in Medical Affairs/Clinical Operations or at a relevant institution or vendor.
- Two or more years of experience managing an individual compassionate use program or Expanded Access Program, or proven experience managing clinical research studies in a professional setting.
Preferred Qualifications:
- Oncology medical or scientific experience is highly desirable.
- Experience managing vendors, with a focus on compliance and regulatory requirements.
- Demonstrated knowledge of protocol design in oncology studies, with a strong understanding of clinical trial management.
- Strong planning and project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.