Regeneron
SeniorManager,PharmacySupportServices
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“Senior Manager, Pharmacy Support Services at Regeneron. Skills: Pharmacy support services, Clinical trial support, Quality assurance. Act as primary SME on investigational product preparation,. Shape development of pharmacy manuals, clinical study documents,”
What You'll Achieve.
Ensure safe, compliant, and streamlined trial execution; Maintain protocol integrity and patient safety; Elevate site experience
What They're Looking For.
Must Have
Bachelor's degree in pharmacy or nursing, 8+ years experience in hospital pharmacy, clinical research, or pharma/biotech, PharmD degree, 6+ years experience in hospital pharmacy, clinical research, or pharma/biotech
Nice to Have
Cell and gene therapy experience
What You'll Do.
Act as primary SME on investigational product preparation
Shape development of pharmacy manuals
clinical study documents
Partner with Clinical Operations
and optimal preparation workflows
Lead or contribute to Kick-Off Meetings
Support review and resolution of IP-related deviations and
Manage ancillary supply compatibility assessments
Provide guidance on IP-related quality assurance issues
Support risk mitigation strategies
Ensure adherence to GCP
Identify opportunities to enhance processes
Elevate site experience through data-driven improvements and feedback
Create engaging training modules for internal teams
Play key role in onboarding new colleagues
Foster a culture of scientific excellence
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical Operations; Formulation Development Group; CDSL leadership; CROs; Site pharmacy teams
Communication Scope
Documentation skills; Presentation skills
Process & Methodology
Manage complex projects
Full Job Description
The **Senior Manager, Pharmacy Support Services** (PSS) serves as a high‑impact subject matter expert in investigational product (IP) management and pharmacy operations across our clinical portfolio. In this role, you will guide best practices for IP handling, preparation, and administration; develop high‑quality pharmacy documentation and training; and support global clinical sites to ensure safe, compliant, and streamlined trial execution. You will partner closely with Formulation Development Group (FDG), Clinical Operations, and CDSL leadership to shape strategy, improve processes, and directly influence the success of our trials. This is an opportunity to elevate your clinical and scientific expertise in a role that blends technical depth, operational leadership, and cross‑functional collaboration. **A typical day in this role looks like:** **Lead Pharmacy & Clinical Trial Support** * Act as the primary SME on investigational product preparation, administration, blinding, and pharmacy‑related ancillary supplies. * Shape the development of pharmacy manuals, clinical study documents, and training materials supporting biologics and gene therapy programs. * Partner with Clinical Operations, CROs, and site pharmacy teams to ensure IP readiness, compliance with regulatory requirements, and optimal preparation workflows. **Drive Study Execution Excellence** * Lead or contribute to Kick‑Off Meetings, Site Initiation Visits, Investigator Meetings, and IP‑focused training for global clinical teams. * Support the review and resolution of IP‑related deviations and practice‑based issues to maintain protocol integrity and patient safety. * Manage ancillary supply compatibility assessments in collaboration with FDG. **Uphold Quality, Compliance & Continuous Improvement** * Provide guidance on IP‑related quality assurance issues and support risk mitigation strategies. * Ensure adherence to GCP, ICH guidelines, and federal/international regulatory standards. * Identify opportuni
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