A pharmaceutical company is seeking a Sr. Clinical Packaging & Labeling Manager to join their team!

As Sr. Manager, Clinical Packaging & Labeling, you will be responsible for packaging, labeling, and IRT activities to ensure continuous drug supply to all global clinical trials.  This position will report to the Director, Supply Chain. 

Responsibilities:

• Manage packaging and open/blinded labeling to ensure the timely release of drug supply for the company's global clinical trials
• Manage clinical drug supply in IRT, including expiry extensions, release of newly packaged drug, and depot transfers
• Ensure inventory levels are maintained at depots and sites
• Partner with key stakeholders (eg. Quality Assurance, Clinical Operations, Regulatory Affairs) and CMO’s to ensure the timely release of drug supply
• Develop and implement appropriate Supply Chain SOPs
• Generate effective tracking tools and performance metric reports
• Lead periodic production schedule meeting
• Domestic or international travel may be required

Preferred Skills, Qualifications and Technical Proficiencies:

• Working experience with global clinical trials and IRT systems is a must
• Working knowledge of cGMPs and familiarity with US and EU regulations
• Working knowledge of drug development process (Phase I-IV)
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative, fast-paced, dynamic environment
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
• Strong attention to detail with excellent follow-up
• Proficient in Microsoft Outlook, Word, Excel, PowerPoint

Preferred Education and Experience:

• BS/BA degree in Life Science or a closely related field
• 6-8 years of experience in a pharmaceutical or biotechnology company
• ASCM CPIM/CSCP certifications preferred