Associate Manager Pharmacy Support Services
About The Position
The Associate Manager, Pharmacy Support (PS) supports activities related to the preparation and administration of investigational product (IP) used in clinical research trials across multiple therapeutic areas, ensuring 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 (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures. Work must be timely, high quality, and compliant with Regulatory Authorities’ regulations and guidelines and Regeneron SOPs. Pharmacy Support Services is part of Clinical Drug Supply & Logistics (CDSL) Operations and works with Drug Product & Development Technology (DPDT), Regulatory Sciences (RS)/Affairs (RA), and Clinical Trial Management team members, including the Clinical Study Lead (CSL), Study Medical Director (SMD), Clinical Scientist (CS), and Quality Management Lead (QML). The role is based in Warren, New Jersey; Armonk, New York; or Rensselaer, New York. Regeneron notes that many roles are required to be performed on-site; applicants should discuss role- and location-specific expectations with the recruiter and hiring manager.
Requirements
- Bachelor’s degree in Pharmacy and/or Nursing with 6 or more years of relevant experience, or 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 or clinical research setting, IDS pharmacy, or equivalent pharmaceutical/biotech industry experience.
- Experience using AI.
Responsibilities
- Collaborate with key partners to support creation of materials for Kick-off meetings (KOM) and Site Initiation Visits (SIV), including information in trial pharmacy manuals and associated documents.
- Search the internet and literature for 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 design of IP preparation.
- 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 may participate in SIVs and Investigator Meetings (IM), providing study-specific pharmacy training to site monitors and participating sites as needed.
- Help determine, resolve, or escalate issues involving quality assurance questions about IP/placebo preparation, administration, or handling at clinical sites; errors in drug preparation or administration to trial participants; ancillary supplies and IP handling instructions versus regulatory filings; and clinical site questions about 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
