Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
Janssen is recruiting for a Global Trial Leader in Managed Access within Global Development Medical Affairs Operations, located in Belgium or other central locations in Europe.
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 exist 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 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 GD Program Leader (GPL), the MAO GTL is accountable for end-to-end operational management of data generation activities or managed access requests. This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.
The MAO GTL 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 GD Program Leader (GPL), GD Operations Head (GOH), Global Trial Leader-Clinical Trial Assistant (GTM-CTA) to ensure overall program delivery at the global, regional and country level.
Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Experience and Skills:
Extensive clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
Specific therapeutic area experience may be required depending on the position.
Project management skills and proficient communication skills are required.
Ability to work in a virtual and highly matrixed environment!
Solid understanding of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
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. Other:
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
Willingness to travel with occasional overnight stay(s) according to business needs
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
United Kingdom-England-High Wycombe- Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France Organization
Janssen Cilag Ltd. (7360) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies