Associate Manager Pharmacy Support Services

Regeneron Pharmaceuticals • Warren, MI

4d

About The Position

The Associate Manager, Pharmacy Support (PS) supports activities related to the preparation and administration of Investigational Product (IP) for clinical research trials across multiple therapeutic areas, helping ensure consistent deliverables across the portfolio. The role creates documentation and training materials to uphold IP management standards, prepares pharmacy manuals and related documentation, and assists clinical site research pharmacists in complying with applicable federal and state regulations, international standards, good clinical practices, and institutional policies and procedures. Activities must be completed on time and with quality, in accordance with regulatory requirements and Regeneron SOPs.

Pharmacy Support Services is part of Clinical Drug Supply & Logistics (CDSL) Operations and collaborates with Drug Product & Development Technology (DPDT), Regulatory Sciences/Affairs, and Clinical Trial Management team members, including the Clinical Study Lead, Study Medical Director, Clinical Scientist, and Quality Management Lead. The position is listed for Warren, New Jersey; Armonk, New York; or Rensselaer, New York.

Requirements

• Bachelor’s degree in Pharmacy and/or Nursing with 6 or more years of relevant experience, or a PharmD with 4 or more years of relevant experience.
• Demonstrated experience with sterile product preparation or administration as a pharmacist or nurse.
• Good understanding of Clinical Supplies and clinical trial design.
• Working knowledge of GCP and ICH guidelines.

Nice To Haves

• Relevant experience in a hospital, clinical research, IDS pharmacy, or equivalent pharmaceutical or biotech industry setting.
• Experience using AI.

Responsibilities

• Collaborate with key partners to create materials for Kick-off meetings and Site Initiation Visits, including information in trial pharmacy manuals and associated documents.
• Conduct internet and literature searches to support reviews of ancillary-supply compatibility information.
• Contact manufacturers for additional information and enter and maintain data in the ancillary supply database.
• Work with DPDT and the Ancillary Supplies team to provide quality information for assessment and procurement, applying pharmacist or nurse expertise.
• Engage appropriate team members to obtain and complete pre-pharmacy-manual documentation, including documentation related to IP preparation design.
• Perform technical and consistency reviews of pharmacy manuals and related documentation.
• Respond to mailbox inquiries from clinical site pharmacists and internal clinical team members using pharmacy or nursing background and experience.
• Maintain department-related materials in Veeva after work is complete.
• Prepare training materials based on pharmacy manuals and, as needed, participate in Site Initiation Visits and Investigator meetings and provide study-specific pharmacy training to site monitors and participating sites.
• Help determine, resolve, or escalate quality assurance questions or issues concerning IP or placebo preparation, administration, or handling at clinical sites.
• Help determine, resolve, or escalate errors in drug preparation or administration to trial participants.
• Help review ancillary supplies and IP handling instructions against regulatory filings.
• Help address questions from clinical trial sites regarding pharmacy manuals.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager