Manager, Clinical Packaging & Supplies

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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. Are you interested in delivering effective, end-to-end collaboration, and training around the globe to accelerate the global development of safe and effective medical therapeutics? If so, this opportunity is for you.

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;
• Design and/or review of labels to meet product requirements and ensure compliance with US and international regulations; and
• Timeline development with associated proactive risk identification, mitigation, and management.
  

Qualifications

• Bachelor’s degree in Pharmacy or related field (MS, Pharm D preferred, with education or experience as potential reciprocal substitutes); Minimum 5 to 10 years 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;
• Ability to interact and persuade by influence internally with Medpace and externally with Sponsor, across all levels of the both organizations; and
• Staying current on industry trends.
  

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 4,000 people across almost 40 countries.

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 historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America’s Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
  

What To Expect Next

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

• WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
  

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