Clinical Supplies Design Leader
Janssen Research & Development, LLC. - Titusville, NJ

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Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Supplies Design Leader - IVRS. This position can be based in either Titusville, NJ; Malvern, PA; or Beerse, Belgium.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide.

Research and developmen

t areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Clinical Supplies Design Leader will be responsible for design and demand management of clinical supplies aligned per Therapeutic Area. The Design Leader develops supply strategies matching needs of clinical study plans to ensure on time delivery and minimal supply overages, manages demand consistent with TA objectives and timelines at a compound level, and manages budgets at a compound level and influences the right study design and its operational impact. This position will influence the clinical teams in the study design and operational aspects thereby ensuring cost efficiency and customer satisfaction and represents the supply management organization on the CMC team.

The Clinical Supplies Design Leader is responsible for design and set-up activities of clinical supplies within J&J Pharma R&D (large and small molecules and for all phases of clinical trials). This position ensures seamless transition and provides support through execution phase of study when needed and fosters strong internal collaborations and relationships with the TAs and Global Clinical Operations to ensure customer satisfaction. The Design Leader will be responsible for developing the IVRS supply specifications and the distribution strategy at trial level and will define kit and label design; while developing excellent working relationships with the other groups within Supply Management and with the Trial Execution Group.

Qualifications

This position requires a minimum of a Bachelor's Degree, with at least 5 years of related experience. Candidates with advanced degrees require a minimum of 2 years experience in clinical supplies. The Clinical Supplies Design Leader must show a high level of clinical supply expertise. General knowledge of GXP/GMP standards are required. Clinical Research/Clinical Operations knowledge is required. Experience with IVRS functionality is required. Good knowledge of project management and demand tools is highly desired along with experience using clinical supply demand simulation tools such as Optimizer. This position can either be based in Titusville, NJ, Malvern, PA, or Beerse, Belgium and may require up to 10% domestic and international travel.

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Primary Location

North America-United States-New Jersey-Titusville

Other Locations

North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Clinical Supplies