Associate Manager Pharmacy Support Services

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 94,000 - 154,000; Full time

Benefits offered by this job

Annual bonuses or other incentiveplans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Vision, life and disability

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Manager, Pharmacy Support to help prepare and administer Investigational Product for clinical trials, ensuring documentation and training materials uphold IP management standards.

You will assist with pharmacy manuals, ensure regulatory compliance (CFR/ICH), and collaborate with DPDT, RS/RA, and CTM teams across multiple sites. Location flexibility includes Warren, NJ; Armonk, NY; and Rensselaer, NY.

Qualifications

• GCP and ICH guidelines knowledge.
• Sterile product preparation or administration experience.
• Experience working with clinical trial design and regulatory expectations.

Responsibilities

• Collaborate with partners to create materials for KOM and SIV and related pharmacy manuals.
• Conduct literature searches to support ancillary supplies compatibility.
• Reach out to manufacturers for information and maintain ancillary supply database.
• Coordinate with DPDT and Ancillary Supplies for quality information.
• Engage with team to obtain pre-pharmacy manual documentation and IP preparation.
• Review pharmacy manual documentation for technical accuracy and consistency.
• Respond to mailbox inquiries from site pharmacists and clinical teams.
• Maintain department materials in Veeva after completion.
• Prepare training materials based on pharmacy manual and contribute to SIV/IM/site training.
• Identify and escalate IP handling or QA issues related to preparation and administration.

Skills

GCP & ICH guidelines knowledge

Sterile product preparation experience

Clinical team communication

Education

Bachelor's degree in Pharmacy and/or Nursing

PharmD with 4+ years experience

Tools

Veeva systems

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).

Responsibilities

• 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 elevate 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.

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

Qualifications

• 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.

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

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
• 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.

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.

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 is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.