Programme Manager

Primary Duties

Reporting to the Head of Expanded Access, the Programme Manager of the Expanded Access Programme will provide operational support to the Head of Expanded Access across the Global EAP programs and related medical affairs activities. The successful candidate will work cross functionally and collaborate with expertise areas within global medical affairs as well as regulatory, supply chain, finance, legal and compliance to ensure compliant and effective execution of regional and local EAP initiatives in according with individual country regulations and within agreed company strategy and budgets.

Summary Of EAP Key Responsibilities

• Set-up, delivery, and maintenance of any new and existing EAP programmes.
• Collaborate with key internal stakeholders to ensure compliant execution of the EAP programme including collaboration with
• Medical Affairs to ensure any new requests are documented and routed for approval
• Regulatory to ensure compliant labelling of the product supply
• Quality to ensure compliance with the organisation's licences and quality processes
• Supply chain to ensure availability of product supply and delivery of EAP supplies
• Finance to ensure the EAP is within pre-approved budget guidelines
• Legal and compliance to ensure programme compliance
• External vendors for any country specific EAP requirements
• For the physicians with patients enrolled in the EAP, ensure provision of EAP protocols and other related documents to ensure safe use of the products and address HCP questions
• Maintain monthly KPI's and ensure all EAP programs are within the specified budget.

Candidate Specification

Skills/Knowledge Required:

• Bachelor's and/or master's degree in life sciences required
• Previous experience within the pharmaceutical industry or CRO
• Experience in managing an expanded access programme preferred
• Experience managing an external vendor partner required including successful negotiation and management of a contract / budget preferred
• Working knowledge of legal, regulatory, and compliance regulations and guidelines preferred

Key competencies include:

• Highly organised individual with proven project management skills, being able to effectively track process and requests and manage an effective archive of information. Excellent attention to detail.

• Excellent interpersonal and communication skills. Works effectively in cross-functional and matrix teams; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
• Excellent time management skills; must be adaptable and flexible to manage competing priorities or high priority requests

• Passionate about making a difference to the lives of patients with rare diseases through directly and indirectly supporting the healthcare professionals (HCPs) that care for them
• Applies entrepreneurial thinking and spirit, and innovative thinking to improve systems and process
• Ability to work effectively in a small organization with a hands-on attitude

To learn more, apply now or contact Anita Osibuamhe at 016321870 or for a confidential discussion today