Clinical Coordinator

Clinical Coordinator

Position Summary:

• Work Schedule: Monday - Friday, 9:00am to 5:30pm
• 100% on-site

Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.

The primary responsibilities of the Clinical Coordinator include creating batch records based on source documentation while identifying customer needs and the ability to prepare batch records following GMP standards. The individual will be client interacting to facilitate customer questions. This position will coordinate receiving of materials as associated with purchase order generation and zero-dollar purchase orders.

The Role:

• Assist Project Managers with development of clinical, stability, and commercial packaging protocols and materials
• Create batch records based on project source documentation from Project Management including primary, secondary labeling and kitting and assembly
• Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records
• Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up
• Create Change Orders and drive resolution to changes required during production
• Work with Label Control to obtain item numbers for labels and randomization copies for batch records; Coordinate receiving and distribution activities, related to item master requests, zero-dollar PO generation, Shipment request completion, as required
• All other duties as assigned

The Candidate:

• High School Diploma or GED is required; Associate’s or Bachelor’s degree is preferred
• At least one year of experience working in a pharmaceutical environment is preferred
• GMP experience is preferred
• Previous experience working in preparation of packaging batch records, packaging, labeling, assembly and distribution of clinical trial materials is preferred
• Individuals will be required to sit, stand, walk, and occasionally lift 0-15 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of PTO + 8 paid holidays
• Generous 401K match 
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any