Program Manager Early Access
Program Manager - Early Access (Pharma) Location: Windsor, UK
Overview: The Program Manager for Early Access will lead and coordinate early access programmes (EAPs) for investigational or pre-approval pharmaceutical products. This role ensures eligible patients in Windsor and the wider UK region can access critical therapies prior to commercial launch, in compliance with MHRA and ethical standards.
Key Responsibilities:
- Oversee the planning, implementation, and management of early access programmes for new or investigational medicines.
- Act as the main liaison between the pharmaceutical client, healthcare providers, regulatory authorities (including the MHRA), and patients.
- Develop and maintain programme documentation, including protocols, patient eligibility criteria, and reporting requirements.
- Ensure all activities comply with UK and international regulations governing early access and compassionate use.
- Collaborate with cross-functional teams (medical, regulatory, supply chain, and commercial) to ensure seamless programme execution.
- Monitor programme performance, track patient outcomes, and provide regular updates to stakeholders.
- Address operational challenges and resolve issues related to patient access, logistics, and compliance.
- Educate healthcare professionals and internal teams on programme processes and requirements.
Qualifications:
- Bachelor's degree in life sciences, pharmacy, nursing, or a related field (advanced degree preferred).
- Proven experience managing early access, compassionate use, or expanded access programmes in the pharmaceutical industry.
- Strong knowledge of UK regulatory frameworks (e.g., MHRA) related to early access.
- Excellent project management, organisational, and communication skills.
- Ability to work collaboratively with diverse stakeholders and manage multiple priorities.
- Experience in the Windsor area or UK healthcare system is an asset.
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