Johnson & Johnson Careers
Trial Supply Manager
Titusville, New Jersey; Malvern, Pennsylvania
Requisition ID: 6976190207
Janssen Research & Development, LLC, a Johnson & Johnson Company, is hiring a Trial Supply Manager.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Trial Supply Manager will:
• Responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines.
• Adapt supply strategies in view of changes in trial execution and ensure a seamless transition from study design phase.
• Assess clinical study recruitment rates and ensure supply planning is adapted accordingly.
• Utilize business tools to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.
• Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution).
• Establish and modify trial specific distribution agreements
• Member of appropriate GCDO clinical trial team.
• Develop strong internal collaboration with GCDO stakeholders to ensure customer satisfaction.
• Interface with GCDO stakeholders at both the Trial and Compound level
• Develop excellent working relationships with the other groups within Supply Management.
• Manage trial supply budget.
• With guidance, manages the activities required to meet First-Patient-In date of clinical trials. This includes initial demand forecasting, configuration of the distribution network, IVR / RTSM specifications, and developing supply strategies to meet clinical plans while optimizing drug overage. Updates therapeutic area representatives on relevant clinical supply chain topics.
• With guidance, responsible for managing all aspects of issue escalation and resolution at the study level.
• Responsible for making transparent any study risks via the cS&OP process.
• Responsible for developing scenario analysis to drive/support decision-making through the cS&OP process.
• Escalation point and interface with the management team via Executive cS&OP, with guidance from Team Lead Focus and scope
• Responsible for the management of all clinical supplies during trial execution within J&J Pharma R&D (large and small molecules and for all phases of clinical trials).
• A minimum of a bachelor’s degree is required.
• A minimum of four (4) years of relevant professional experience is required; preferably in a clinical supply related role.
• General knowledge of GxP principles is required.
• Experience with the following functions is preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management
• Experience with clinical supply demand management tools is preferred (e.g., tcVisualize, IVRS, SAP, OMP+)
• Intermediate to advanced software skills (e.g., Microsoft Excel, Powerpoint) are required.
• Excellent written and oral communication skills and organizational skills are required
• This position can be located in Titusville, NJ or Malvern, PA and may require up to 10% of travel.
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.
United States-New Jersey-Titusville-
Janssen Research & Development, LLC. (6084)