TRIAL SUPPLY MANAGER Job

Job description

TRIAL SUPPLY MANAGER-1500062216WDescription“Design, plan, make, source, deliver!” The Clinical Supply Chain holds the global responsibility of all clinical supplies of Janssen Research & Development portfolio and the Global Medical Affairs portfolio. The ~280 employees in the clinical supply chain team have access to the end to end supply chain network. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of clinical supplies. Through a global network and organization (US, Switzerland, Belgium, Ireland, Netherlands, India), we are responsible for the manufacturing and scale-up of small and large molecules products in development and low volume commercial supply, and secure the supply to more than 60.000 patients in more than 330 clinical trials every year. Because of the complexity, the variety of projects, the connection with all customers and suppliers including 3rd party vendors and the innovative character of this department, the employees can have big impact on decision making and the flexibility to do more.
In this environment we are currently looking for a:Trial Supply ManagerThis individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines:
- Adopt 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 adopted 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 GCO clinical trial team.
- Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction.
- Interface with Global Trial Managers.
- Manage trial supply budget.
- Develop excellent working relationships with the other groups within Supply.
QualificationsCritical Experience Required
- A university/bachelor’s degree (or equivalent experience) and 4-6 years’ experience preferably in a clinical supply related role;
- Experience with clinical supply demand management tools preferred (e.g., tcVisualize, IVRS, SAP);
- Experience with the following functions preferred: clinical supply pack/label/distribution , clinical trial operations, project management, pharma/bio research and development, inventory management;
- General knowledge of GxP principles;
- Intermediate to advanced software skills (e.g., Microsoft Excel, Powerpoint);
- Minimum 80% FTE required.
Critical Compentences:
- Excellent written and verbal communication skills;
- Strong planning and cross-functional coordination skills;
- Strong attention to detail;
- Ability to work independently with some coaching;
- Ability to multi-task and manage complexity;
- Ability to work in a high pressure environment;
- Solution oriented;
- Exceptional collaboration skills;
- Integrity and Credo Based-actions.
Location: US, EuropeTravel: 10%Language requirement: EnglishPrimary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Pharmaceutica N.V. (7555)Job Function: R&D