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About the Role
The Associate Manager, Pharmacy Support (PS) is responsible for supporting activities related to the preparation and administration of Investigational Product (IP) used in clinical research trials. This role ensures consistent deliverables across the portfolio by creating documentation and training materials to uphold IP management standards. It involves preparing the pharmacy manual and related documentation, and assisting clinical site research pharmacists in compliance with regulations and institutional policies.
Responsibilities
- Collaborates with key partners to support creation of materials for Kick-off meetings (KOM) and Site Initiation Visit (SIV) as it pertains to information in the trials’ pharmacy manuals and associated documents.
- Performs internet and literature searches to support review of ancillary supplies compatibility information.
- Contacts manufacturers for additional information and performs data entry and maintenance of ancillary supply database.
- Works with DPDT and Ancillary Supplies team to provide quality information for assessment and procurement.
- Engages with appropriate team members to obtain and complete pre-pharmacy manual related documentation including design of IP preparation.
- Performs technical and consistency reviews of pharmacy manual and related documentation based on technical expertise.
- Responsible for responding to mailbox inquiries from clinical site pharmacists and internal clinical team members.
- Responsible for documentation maintenance of department related materials in Veeva once work is complete.
- Prepares training materials based on the pharmacy manual.
- May participate in Site Initiation Visits (SIV), Investigator meetings (IM) and provide study specific pharmacy training to site monitors and participating sites as needed.
- Assist to determine, resolve and/or escalate any issues related to quality assurance questions/issues related to the IP/placebo as related to preparation and administration, or handling at clinical sites, any errors that occur in drug preparation and administration to trial participants, review ancillary supplies and IP handling instruction versus regulatory filings, questions proposed by the clinical trial sites in regard to the pharmacy manual.
Requirements
- Bachelors degree in Pharmacy and/or Nursing & 6+ years relevant experience or PharmD & 4+ years relevant experience
- Relevant experience in hospital or clinical research, IDS pharmacy or equivalent pharmaceutical/biotech industry experience is helpful.
- Demonstrated experience with sterile product preparation or administration experience as a pharmacist or nurse.
- Good understanding of Clinical Supplies / Clinical Trial design.
- Working knowledge of GCP and ICH guidelines.
- AI usage experience is helpful.
Skills
- Pharmacy
- Nursing
- Clinical Research
- Investigational Product (IP) management
- GCP
- ICH guidelines
- Veeva
Location
- Warren, NJ
- Armonk, NY
- Rensselaer, NY
Work Type
- On-site
Experience Level
- Associate Manager
Education Level
- Bachelors degree in Pharmacy and/or Nursing
- PharmD
Salary/Compensations
- $94,000.00 - $153,600.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Pharmacy Support Services sits within Clinical Drug Supply & Logistics (CDSL) Operations and works with Drug Product & Development Technology (DPDT), Regulatory Sciences (RS)/ Affairs (RA), as well as members of the Clinical Trial Management team (CTM) including the Clinical Study Lead (CSL), Study Medical Director (SMD) and Clinical Scientist (CS), Quality Management Lead (QML).
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.