Pharmacy Support Lead – Clinical Trials & IP Prep

Regeneron Pharmaceuticals, Inc.; New Jersey; Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager, Pharmacy Support to oversee pharmacy manual development, IP handling, and training preparation for clinical trials.

You will collaborate with cross-functional teams to ensure regulatory compliance and timely deliverables across therapeutic areas. The role requires strong knowledge of GCP/ICH guidelines, experience with pharmaceutical documentation, and the ability to educate site pharmacists and trial staff.

Formación

• Bachelors in Pharmacy or Nursing or PharmD with 4+ years of relevant experience.
• Experience in hospital or clinical research settings is preferred.
• Knowledge of GCP and ICH guidelines is required.

Responsabilidades

• Collaborates to create materials for KOM and SIV for pharmacy manuals.
• Performs literature searches and contacts manufacturers for data.
• Maintains IP-related documentation in DPDT and ancillary supplies records.
• Designs IP preparation processes and conducts consistency reviews of manuals.
• Responds to mailbox inquiries from site pharmacists and clinical teams.
• Maintains department materials in Veeva after tasks are completed.
• Develops training materials and may conduct site training sessions.

Conocimientos

Pharmacy knowledge

Regulatory compliance

Documentation

Training materials

IP management

Educación

Bachelor's degree in Pharmacy

Nursing degree

PharmD

Herramientas

Veeva

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager, Pharmacy Support to oversee pharmacy manual development, IP handling, and training preparation for clinical trials.

You will collaborate with cross-functional teams to ensure regulatory compliance and timely deliverables across therapeutic areas. The role requires strong knowledge of GCP/ICH guidelines, experience with pharmaceutical documentation, and the ability to educate site pharmacists and trial staff.