Sr. Manager, Pharmacy Support Services

The Senior Manager, Pharmacy Support Lead (PSL) is responsible for driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio. In particular, the role partners with Formulation Development Group (FDG), as a SME in investigational product handling, preparation, and administration. As such, the role drives creation of documentation & training materials to ensure that best practices for IP management are upheld and looks for opportunities to improve the process. Focuses on clinical site research pharmacy support in compliance with applicable federal (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures. The role provides consultation and lends expertise to Clinical Drug Supply & Logistics Organization (CDSL), the Formulation Development Group (FDG), the Clinical Trial Management Team (CTM), and partner groups on investigational products and medication/device related issues, such as aseptic IP preparation, concomitant medications, Instructions for Use (IFU), and patient compliance/adherence issues.A typical day as a Sr Manager in this role looks like:Partners with the CDSL Managers, the Formulation Development Group (FDG), Regulatory Sciences (RS)/ Affairs (RA), as well as members of the Clinical Trial Management team (CTM) including the Clinical Study Lead (CSL), Study Medical Director (SMD) and Clinical Scientist (CS), Quality Management Lead (QML).Provides consultation on various pharmaceutical aspects including site pharmacy operations as pertains to ancillary supplies, investigational product (IP) labeling & design, blinding issues, preparation, and administration of IPs for all REGN-funded/sponsored clinical trials.Provides technical expertise for the development of clinical study documents and pharmacy manuals and will assist in development of admixture, dosing, and administration strategies for complex biologic products and gene therapies.Collaborates with key partners to drive study activities including development of Pharmacy Manuals and associated forms, ensuring research site pharmacy requirements, and provides communication and coordination of pharmacy related activities.Works closely with Clinical Operations, CRO representative and pharmacy site personnel to coordinate matters related to the clinical trial IP, including:ensuring that the proposed IP and its placebo used in the clinical trial will maintain the blind during preparation and administration and meet regulatory requirements for use in the proposed country.triage and review of ancillary supplies compatibility requests in conjunction with FDG utilizing search queries and entry in the associated database.review and resolution of practice-based deviations and violations involving the IP/placebo during the trial.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 trial participants,questions proposed by the clinical trial sites regarding IP preparation and administration.Partners closely with Clinical Ops and Clinical Study personnel during protocol development, protocol progress, and subsequent amendments.Lends expertise to Site Initiation Visits (SIV), Investigator meetings (IM) and provides study specific pharmacy training to site monitors and participating sites as needed.Establishes and consolidates data from Site Feedback mechanisms and support efforts to continually improve processes to meet Sponsor and site needs in an efficient and consistent manner.Aids in training/ on-boarding of new colleagues and development of training material for internal and external stakeholders.This role may be for you if you have:Experience in sterile product preparation/administration experience.Strong understanding of drug product infusion via various route of administration.Understanding of Clinical Supplies / Clinical Trial design.Must be able to effectively communicate across all levels; analytical problem-solving experience; must be able to develop and present varied and unique ideas; effective influence and negotiation skills.Ability to build successful collaborations with internal and external partners; Must have strong communication skills; verbal, written, and presentation; Must have broad knowledge and cross-functional understanding of clinical trial methodology; Working knowledge of GCP and ICH principles. Knowledge of PCAB, FDA, NABP/VPP, USP 795 & 797, EU CTR guidelines.In order to be considered qualified for this role,

a minimum of a Bachelors Degree in Pharmacy or Nursing, or PharmD is required, and at least 8 years of relevant experience in Hospital or Clinical Research or equivalent pharmaceutical/biotech industry experience.

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