Senior Manager, Pharmacy Support Services

As a Senior Manager, Pharmacy Support Services, a typical day might include:

Driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio. This role partners with Development Operations as a SME in investigational product handling, preparation and administration. You will drive the creation of documentation & training materials to ensure that best practices for IP management are upheld. There is a focus on clinical site research pharmacy support in compliance with applicable federal (CFR and ICH E6) and state regulations, international standards, good clinical practices, and institutional policies and procedures. You will provide consultation within Clinical Drug Supply & Logistics Organization (CLO), the Formulation Development Group (FDG) and partner groups on investigational products and medication/device related issues, such as aseptic IP preparation, concomitant medications, exclusionary medications and patient compliance/adherence issues.

This role might be for you if you can provide Pharmacy Support including:

• Provide technical expertise for the development of clinical study documents and manuals and will to assist in development of admixture, dosing and administration strategies for complex biologic products.

• Collaborate with key partners to drive study activities such as site pharmacy evaluation and establishment, development of Pharmacy Manuals and associated forms, and focus on communication and coordination of pharmacy activities with the study sites.

• Work closely with Clinical Operations, CRO representative and pharmacy site personnel to coordinate matters related to the clinical trial supply, including:

  • Ensuring that the proposed IP and its placebo to be used in the clinical trial meet all regulatory requirements for use in the proposed country;

  • Review and approval of all relevant product labels to be used in the clinical trial;

  • Review and resolution of practice-based deviations and violations involving the IP/placebo during the course of the trial.

• The incumbent is responsible to determine, resolve and/or escalate any issues related to, but not limited to:

  • Quality assurance questions/issues related to the IP/placebo;

  • Any errors that occur in drug preparation and administration to subjects;

  • Any instance that potentially affects the quality, identity, strength, or purity of the IP/placebo (including but not limited to temperature excursions, expiry dating, and questions related to repackaging, labeling).

• Unblinded to studies and works closely with Clinical Drug Supply & Logistics Manager, Clinical Study Lead, Formulation Development and investigative site representatives by providing consultations on various pharmaceutical aspects of protocol development and processes such as issues with site pharmacy operations as pertains to supplies, labeling & design, packaging, blinding, administration, and distribution of IPs for all REGN-funded/sponsored clinical trials.

• Partner closely with Clinical Ops and study personnel during protocol development, protocol progress, and subsequent amendments.

• Lend expertise to Site Initiation Visits and provide study pharmacy training to CRA and participating sites as needed.

• The role will establish and consolidate feedback from Site Feedback mechanisms and support efforts to continually improve processes to meet Sponsor and site needs in an efficient and consistent manner.

• Must be able to communicate across all levels; Analytical problem solving experience;

• Must be able to develop and present varied and unique ideas; Effective influence and negotiation skills.

To be considered for this opportunity, you must have the following:

• A degree in Nursing with at least 8 years of Clinical/Experience or equivalent pharmaceutical/biotech industry experience.

• Hospital or Clinical Research experience.

• Sterile product administration  experience.

• Understanding of Clinical Supplies / Clinical Trial design.

• Working knowledge of GCP and ICH. Knowledge of PCAB, FDA, NABP/VPP, USP 795 & 797 guidelines.

• Must have broad knowledge and cross-functional understanding of clinical trial methodology

• Ability to build successful collaborations with internal and external partners; Must possess strong interpersonal skills including; verbal, written, and presentation;

Preferred Qualifications:

• Clinical Research Experience preferred.

• Infusion administration experience, esp. oncology

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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