Clinical Logistics Associate II

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
12021BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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.

Summary:
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).

Responsibilities:

Supply Planning
• Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
Inventory tracking
• Tracks investigational product (IP) inventory.
Shipments
• 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.
Temperature excursions
• 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.
Expiry Management
• Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Ancillary Supplies
• 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 File.
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
Vendor Management
• Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
Staff Management
• Does not supervise staff.
Process Initiatives
• Assists with implementing process initiatives in accordance with business needs.
Metrics
• Tracks metrics related to drug supply processes.
Training
• May assist in training and development as needed.
Reporting
• Compiles reports of supply status to study teams and clinical logistics team as needed.
Problem solving
• Applies knowledge of company policies and standard practices to resolve problems.

Requirements:
Bachelor's Degree and at least 3 years relevant clinical supply management experience within the biotechnology/pharmaceutical industry.
Fundamental knowledge of the clinical drug development process and clinical trial methodology; Fundamental knowledge of ICH/GCP and regulatory guidelines/directives; Effective communication and interpersonal skills; Good computing skills, with competency in MS Word and Excel; Ability to build relationships internally and externally; Problem solving and troubleshooting abilities.

Success factors:
Integrity and Trust
Peer Relationships
Drive for Results
Dealing with Ambiguity
Learning on the Fly
Individual Courage
Customer Focus

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.

Requisition Number: 12021BR