Clinical Logistics Associate II - Tarrytown
Employment Type: Full-Time
Industry: Scientific Research
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Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Clinical Logistics Associate II provides support to the Clinical Logistics group and IP distribution process for one or more molecules across multiple Therapeutic areas. May provide support to the clinical logistics manager in managing clinical drug supply for one or more early phase clinical studies. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs / WPDs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Interacts with clinical trial managers, as well as staff from quality, clinical compliance, clinical logistics and IOPS (CMC, external manufacturing, stability).
Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
Tracks investigational product (IP) inventory.
Independently initiates IP shipment orders according to supply plans or as requested by Clinical Logistics Manager or Clinical Trial Management team; tracks orders from shipment through receipt at investigator study sites; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites.
Processes, reviews and evaluates temperature excursion reports from clinical sites and communicates stability information and/or product acceptability to clinical trial managers, CROs, and investigator sites.
Returns & Destruction
Provides support in reviewing, tracking and/or archiving IP returns documentation.
Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Facilitates ancillary supply shipments to investigator sites. Manages in-house inventory. Documentation
Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master
Study Team Interaction
Interacts with Clinical Study teams to act on specific trial needs. Works with functional groups to provide and receive information required for achievement of individual or team assignments, goals and
objectives. Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution
Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
Does not supervise staff.
Assists with implementing process initiatives in accordance with business needs.
Tracks metrics related to drug supply processes.
May assist in training and development as needed.
Compiles reports of supply status to study teams and clinical logistics team as needed.
Applies knowledge of company policies and standard practices to resolve problems.
At least 3 years relevant clinical supply management experience within the biotechnology/pharmaceutical industry.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Associated topics: antibody, aseptic, biopharma, dietary, disease, health, industrial hygienist, medicine, metabolism, microbiological
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