Pharmacy Support Manager, Clinical Trials

BioSpace

New Jersey

On-site

USD 94,000 - 154,000

Full time

4 days ago
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Benefits offered by this job

Health insurance
401(k) match
Paid time off
Dental/vision insurance

Job summary

Regeneron is seeking an Associate Manager, Pharmacy Support to assist in preparation and administration of Investigational Product for clinical trials across therapeutic areas. You will create documentation and training materials to uphold IP management standards, prepare the pharmacy manual, and support site pharmacists in compliance with CFR, ICH E6, GCP, and internal policies.

The role is based onsite at Warren, NJ with travel as needed and collaboration across DPDT, RS/RA, CTM, and QA teams

Qualifications

  • Experience in hospital or clinical research environments.
  • Demonstrated experience with sterile product preparation or administration.
  • Knowledge of GCP and ICH guidelines.
  • Bachelor's degree in Pharmacy and/or Nursing or PharmD.
  • AI usage experience is helpful.

Responsibilities

  • Assist in creation of IP preparation materials and pharmacy manuals.
  • Support preparation and administration of Investigational Product for trials.
  • Review and maintain documentation in Veeva and associated systems.
  • Provide pharmacy training and Site Initiation Visit support as needed.
  • Respond to inquiries from clinical site pharmacists and team members.

Skills

Pharmacist experience
Clinical research
GCP & ICH knowledge
Sterile product prep
AI usage experience

Education

PharmD with 4+ years
Bachelors in Pharmacy or Nursing

Job description

Regeneron is seeking an Associate Manager, Pharmacy Support to assist in preparation and administration of Investigational Product for clinical trials across therapeutic areas. You will create documentation and training materials to uphold IP management standards, prepare the pharmacy manual, and support site pharmacists in compliance with CFR, ICH E6, GCP, and internal policies.

The role is based onsite at Warren, NJ with travel as needed and collaboration across DPDT, RS/RA, CTM, and QA teams

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