Manager, Clinical Packaging & Supplies

Job Description

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,200 people across 40 countries.

Job Summary

We are seeking a Manager, Clinical Packaging and Supplies to organize and execute activities involved with the management of investigational product and associated ancillary supplies in support of clinical studies. This position will be an integral part of the Medpace clinical operations team.

Responsibilities

• Development and management of timelines associated with the delivery of Investigational Product;
• Management of packaging, labeling, storage, and distribution of Investigational Product;
• Procurement and distribution of ancillary supplies, comparative agents, and/or protocol driven baseline therapies;
• Forecasting/projecting Investigational Product and ancillary supplies to meet country approval, depot set up, site initiation, and patient enrollment
• Proactively perform and manage risk associated with timeline changes, addition or deletion of depots, countries, sites, and enrollment variances;
• Proactively account for, and manage, expected overages and unexpected losses;
• Proactively manage and perform risk assessment of use-by date of Investigational Product and supplies, along with need for Just in Time labeling, date extension labeling, and/or product resupply;
• Collaborate with IRT, Sponsor, and clinical study team to develop IRT specifications, perform User testing, as may be necessary to support site initiation, site resupply, patient dosing;
• Directly or indirectly manage third party packaging, labeling, storage, distribution vendors and international depots; and
• Design and/or review of labels to meet product requirements and ensure compliance with EU and international regulations.

Qualifications

• Bachelor’s degree in Pharmacy or related field (MS, Pharm D preferred, with education or experience as potential reciprocal substitutes);
• Significant direct experience in clinical supply management from start-up to close-out, including planning, labeling, packaging, release, storage, distribution, reconciliation, returns, and destruction;
• Knowledge of pharmaceutical stability protocols;
• Knowledge of GMP batch record development, review, approval, and release processes;
• Demonstrated knowledge and application of FDA, DEA, Customs/Import, and DOT standards and regulations;
• Knowledge of GCP and global cGMP regulations, including QP release;
• Demonstrated knowledge of warehousing, distribution, and logistics (including cold chain distribution);
• Multi-therapeutic experience across varied product presentations and storage conditions;
• Excellent project management and communication skills;
• Flexibility and confidence to work in at-risk and changing environment, for multiple concurrent clinical studies; and
• Ability to interact and persuade by influence internally with Medpace and externally with Sponsor, across all levels of the both organizations.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards

• Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
• Winner of the ACRP-Avoca CRO Quality Award in 2018
• Recognized with six CRO Leadership Awards from Life Science Leader magazine
• Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships

What to Expect Next

We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

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