Medical Affairs Expanded Access Manager
An oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer is advertising a vacancy for a Medical Affairs Expanded Access Manager. Our team of passionate associates develops and commercialize safer and more effective supportive care agents and therapeutics. Based in Switzerland, this role is an exciting opportunity to work with a company that provides transformative therapies worldwide.
- Providing coordination support for EAPs.
- Ensuring filing and tracking of EAP related documents, agreements, contracts and key correspondence.
- Under direction, providing regular status and issues reports to Teams and Senior Management.
- Proactively identifying potential delivery issues and risks and ensures corrective actions in case of deviation, communicates to stakeholders.
- Responsible for defining project management elements and tracking of milestones and timelines.
- Responsible for timely assessment of Patient Approval Forms against entry criteria compliance (and agreed patient intakes by month and country); proactively escalates deviations and exception requests.
- Maintaining an overview of vendor held stock levels and raises requests for resupply.
- Proactively incorporating learnings and recommendations from one EAP to another; identifies needs for process standardisation and regulatory compliance direction.
- Under direction, developing project materials and tools to support effective operationalisation and communication.
- Under direction, developing materials and tools to support a streamlined and effective transition from Investigational Medicinal Product (IMP) to locally approved commercial presentations.
Skills and Requirements:
- Background in Life Sciences preferred.
- Minimum of 3 years of professional experience in the pharmaceutical industry.
- Broad understanding of the expectations of EU Health Authorities.
- Understanding of cross-functional EAP stakeholder key responsibilities (Supply Chain, Regulatory, PV, Legal, Medical Writing, LOC Medical Leads, etc.)
- Knowledge of drug development.
- Strong planning and project management skills.
- Commitment to acting in line with legal, regulatory and company standards and codes of practice.
- Proven success working in a team setting and contributing to team success.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Strong organisational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
- Strong problem-solving skills.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Comfortable with ambiguity and has the ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Self-motivated, assertive, and self-confident, with the ability to act with urgency and passion.
- Flexible, resourceful, creative, enthusiastic, and results-oriented.
- Enjoys working in a fast-paced environment.
- Good interpersonal skills, including presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Patrick Franke at +44 02074400632 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.