Associate Manager Pharmacy Support Services

Regeneron Pharmaceuticals, Inc.; Warren (MI); On-site; USD 94,000 - 154,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager, Pharmacy Support to ensure preparation and administration of Investigational Product for clinical trials.

You will create documentation and training materials to uphold IP management standards, and assist clinical site pharmacists in regulatory compliance across CFR, ICH, and internal SOPs. Role involves preparing the pharmacy manual and related documents, maintaining Veeva records, and providing IP handling training for site

Qualifications

• Pharmacist or nurse with hospital/clinical research exposure.
• Understanding of Clinical Trials and GCP/ICH guidelines.
• Experience with sterile product preparation or administration is preferred.
• Strong documentation and data management skills.

Responsibilities

• Support creation of IP preparation documentation and pharmacy manuals.
• Prepare training materials and participate in SIV/IM meetings as needed.
• Respond to mailbox inquiries from clinical site pharmacists and internal teams.
• Maintain department materials in Veeva after work completion.
• Collaborate with DPDT, RS/RA, and CTM to ensure IP handling conforms to regulations.

Skills

Clinical research

GCP/ICH guidelines

Pharmacy background

Data management

Education

PharmD

Bachelor's in Pharmacy

Bachelor's in Nursing

Tools

Veeva

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.

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 experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)
$94,000.00 - $153,600.00