Lead Trial Supply Management Specialist

Jobinhalt

Janssen Pharmaceutical Companies, a member of the Johnson & Johnson Family of Companies, is recruiting for a Lead Trial Supply Management Specialist. This position is located in Wayne PA, Titusville, NJ & in Beerse, Belgium.

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 (file:///C:/Users/kfriel1/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/4OM9Y010/www.janssen.com) and follow us @JanssenGlobal. Janssen BioPharma, Inc. is part of the Janssen Pharmaceutical Companies.

Key Responsibilities

• Ensure a seamless transition from early study design phase
• With some guidance, manages the set-up activities required to meet First-Patient-In date of clinical trials
• Retrieval of initial demand forecast from Global Development (GD)
• Initiation of the clinical label to support regulatory submissions
• IVR / RTSM specification development
• Adapt supply strategies in view of changes in trial execution
• Utilize business tools (e.g. IRT) to manage inventories at depots and sites, ensuring on-time delivery of clinical supplies for patient dosing
• With some guidance, responsible for managing all aspects of supply related issue escalation and resolution at the study level. (e.g., packaging, distribution)
• Perform required quality reviews and close-out activities, storing appropriate documents in relevant systems
• Develop strong internal collaboration with Global Development (GD) stakeholders to ensure customer satisfaction
• Connect with Global Development (GD) on recruitment forecast and assess changes to plan on a periodic basis
• Primary point of contact for Global Development (GD) trial teams, keeping them informed of current supply plans and any associated risks
• Member of appropriate Global Development (GD) clinical trial teams, regularly providing clinical supply updates
• Interface with Global Development (GD) stakeholders, at both the Trial and Compound level on relevant clinical supply chain topics
• Regularly assess clinical study recruitment rates and ensure supply planning is adapted accordingly
• Responsible for making transparent any study risks via the cS&OP process
• Responsible for identifying and 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 some guidance from Team Lead
  

Education

Qualifications

• A university/bachelor’s degree (or equivalent experience) and 6-8 years of experience preferably in a clinical supply related role
• General knowledge of GxP principles
  

Experience And Skills

Required:

• 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 and oral forms.
• Strong project execution and cross-functional coordination skills, able to build strong collaborative teams and relationships, leading cross functional/ virtual teams where required, contributes to employee engagement.
• Foundational understanding of clinical trials and underlying dynamics to optimize global P&L and Distribution processes and interdependencies with Clinical Operations
  

Preferred:

• Strong attention to detail
• Ability to work independently with limited coaching
• Ability to multi-task and manage complexity
• Solution oriented
  

Other:

• Experience with clinical supply demand management tools preferred (e.g., tcVisualize, IVRS, SAP, OMP+)
• Intermediate to advanced software skills (e.g., Microsoft Excel, OneNote, PowerPoint)
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

Primary Location

United States-Pennsylvania-Wayne-955/965 Chesterbrook Blvd

Other Locations

Belgium-Antwerp-Beerse, United States-New Jersey-Titusville

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206058061W