Johnson & Johnson

Global Trial Leader in Managed Access

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Job Description

Job Description:

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 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.

Key Responsibilities:

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.

Qualifications

Education:

  • Master's or Bachelor’s preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

Experience and Skills:

Required:

  • Minimum of 8 years of 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.
  • Strong working knowledge 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

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 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
Belgium-Antwerp-Beerse-
Other Locations
Netherlands, Poland, United Kingdom, Germany
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2005845222W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist
  • Voor deze functie is er geen minimale werkervaring vereist
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