Johnson & Johnson Careers
Trial Supply Manager
Requisition ID: 1905740113W
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.
- 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).
- General focus on large, complex studies.
- Act as role model within team for use of core processes and proper use of systems and tools
- Takes accountability for own performance and development seeking opportunities to broaden knowledge and subject matter expertise.
- Support business process improvement initiatives.
- 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 is located in Beerse (BE) and may require up to 10% of travel.
- Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms
- Strong planning and cross-functional coordination skills, able to build strong collaborative teams and relationships, leading cross functional/ virtual teams where required, contributes to employee engagement
- Gathers diverse viewpoints and able to influence key stakeholders within the Clinical Supply Chain, and other key cross functional partners
- Strong attention to detail
- Ability to work independently with limited coaching
- Ability to multi-task and manage complexity
- Ability to work in a high-pressure environment, acts with speed, flexibility, and accountability to achieve goals.
- Solution oriented
- Exceptional collaboration skills
- Integrity and Credo Based-actions
Janssen Pharmaceutica N.V. (7555)