Temp Clinical Study Operations Specialist 

Pay Rage: $29.79 - $44.15/hr

Onsite Role in Basking Ridge, NJ

12 Month Contract 

The Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, and ancillary supplies process, for one or more molecules across multiple Therapeutic areas supporting moderately sophisticated studies as well as short-term departmental projects and ongoing continuous improvement initiatives. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.

A typical day will include the following:

IP Supply & Inventory Planning

Accountability, Reconciliation, Returns & Destruction (ARRD)

Internal System Management including lot creation, batch status, and inventory maintenance

Assessment and Oversight activities (risks, stocking levels, trends)

IP Shipments

System and Non-system generated Shipments

Depot transfers

Temperature Excursion Management

IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)

Expected Document List (EDL) creation

eTMF Document Management per regulatory requirements

QA/QP Release Management

Pack-and-label kit and sequence reconciliation

Inspection Readiness activities

IRT management activities including IRT Alert management and UAT activities

Suspected Serious Non-Compliance support

Ancillary Supply & Inventory Planning/Management

Procurement support

Supply Planning & Inventory management

Shipping & logistics activities

Temperature Excursions

Lot management

eTMF activities

ARRD activities

This role might be for you if:

You have fundamental knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners

Fundamental knowledge of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives

Proficient in MS Word & Excel

Efficient Problem Solving

Excellent Time Management

Thrives in Ambiguity, Committed, Adaptability, Collaborates Optimally, Well Organized, Communicates Optimally, Detail Oriented

To be considered for this opportunity, you must have at minimum a Bachelor's Degree with 1+ years of work experience in the following fields: Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, Manufacturing, Or equivalent research/commercial biopharma experience. This is a hybrid role, requiring you to be on-site 4 days.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation