Clinical Trials Pharmacy Support Lead

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

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