Pharmacy Support Lead for Clinical Trials & IP Prep

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

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.