Associate Manager Pharmacy Support Services

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks an Associate Manager, Pharmacy Support to back Investigational Product preparation and administration for clinical trials.

You will create documentation and training materials to uphold IP management standards and assist clinical site pharmacists in compliance with CFR, ICH E6, and Regeneron SOPs. The role sits within Clinical Drug Supply & Logistics (CDSL) Operations and collaborates with DPDT, RS/RA, and CTM teams to develop pharmacy

Qualifications

• Bachelor's degree in Pharmacy and/or Nursing with 6+ years relevant experience, or PharmD with 4+ years.
• Experience in hospital or clinical research, IDS pharmacy or biotech industry helpful.
• Experience with sterile product preparation or administration as a pharmacist or nurse.
• Strong understanding of Clinical Supplies / Clinical Trial design.
• Working knowledge of GCP and ICH guidelines.
• AI usage experience is helpful.

Responsibilities

• Collaborate to create materials for KOM and SIV for pharmacy manuals and related documents.
• Perform internet and literature searches, contact manufacturers, and maintain ancillary supply database.
• Provide quality information for assessment and procurement with DPDT and Ancillary Supplies.
• Review pharmacy manual and related documentation for technical accuracy.
• Respond to mailbox inquiries from clinical site pharmacists and internal teams.
• Maintain department materials in Veeva once work is complete.
• Prepare training materials and participate in SIVs, Investigator meetings and site training.
• Resolve QA questions related to IP/placebo handling and regulatory filings.

Skills

Sterile product preparation

Clinical trial design

GCP & ICH guidelines

AI usage

Education

Bachelor's degree in Pharmacy

Nursing

PharmD

Job description

Build our future together:

The Associate Manager, Pharmacy Support (PS) is responsible for supporting activities related to preparation & administration of Investigational Product (IP) used in the conduct of clinical research trials across multiple therapeutic areas to ensure consistent deliverables across our portfolio. The role requires creation of documentation and training materials to ensure that standards for IP management are upheld. The role involves preparation of the pharmacy manual & related documentation and assistance to the clinical site research pharmacists in compliance with applicable federal (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures. Activities are performed on time, with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs

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).

When & where:

Location: Warren, NJ / Armonk, NY / Rensselaer, NY

Discover your role:

• Collaborates with key partners to support creation of materials for Kick-off meetings (KOM) and Site Initiation Visit (SIV) with collaborators, 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. Bases decisions and collaboration with DPDT and Ancillary Supplies on expertise as a pharmacist or nurse.
• 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 using pharmacy or nursing background and experience.
• Responsible for documentation maintenance of department related materials in Veeva once work is complete.
• Prepares training materials based on the pharmacy manual and prepares 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 escape any issues related to, but not limited 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.

This role requires:

• 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.

Does this sound like you?

Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture.

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and