Global Trial Leader Managed Access
Janssen is recruiting for a Global Trial Leader (GTL) in Managed Access within Medical Affairs Operations, located in Belgium, The Netherlands, France, Germany, Poland, Spain, UK or Italy.
At Janssen, we believe it is our ethical obligation to provide access and care to patients in need. Managed Access is the provision of an investigational product, outside of a clinical trial, to treat patients with serious/life threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted. The Managed Access team within Global Development (GD) Medical Affairs Operations (MAO) are responsible for the operational planning, management and execution of all Managed Access initiatives globally including Pre-Approval Access and Post-Trial Access programs. By flawlessly managing Managed Access requests and providing access to investigational treatment that are not yet approved for use by health authorities we give new hope to people in need.
- Reporting to the MAO Global Program Leader (GPL) or Associate Director Global Trial Leader (AD GTL), the GTL MAO Managed Access is accountable for operational management of managed access initiatives. This includes start-up, execution and close-out according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.
- The GTL MAO Managed Access serves as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Global Program Leader (GPL), Global Operations Head (GOH), Global Trial Leader-Clinical Trial Assistant (GTM-CTA) to ensure overall program delivery at the global, regional and country level.
- The MAO GTL might contribute to or lead (cross-) functional process initiatives
- Internal contacts: GOHs, GPLs, (AD) GTLs and G-CTAs, Global, Regional and Country Medical Affairs teams, Clinical Development Teams, GD functions, Finance Department, Legal, Procurement, Regulatory, Quality Management & Training group; Study Management Teams, and other J&J enterprise sectors, as applicable.
- External contacts: external service providers, physicians and their staff.
- Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Experience and Skills:
- 8 years of clinical trial experience in the pharmaceutical industry or CRO. Managed Access experience preferred. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Project management skills and proficient communication skills are required.
- Ability to work in a virtual and highly matrixed environment.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and strong financial management skills.
- Leadership skills and ability to influence without authority.
- Be an agent of change management.
- Excellent knowledge of English
- Willingness to travel with occasional overnight stay(s) according to business needs.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-PolandOrganization
Janssen Pharmaceutica N.V. (7555)Job Function
Er is geen minimale opleiding vereist