Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated individual to join our Labeling Operations team as a Clinical Labeling Project Coordinator embedded within our Supply Chain department. As part of this opportunity, the incumbent will work with functional groups including Clinical Labeling, Quality, Clinical Operations, Package Engineering, Supply Chain, Regulatory and Project Management staff to meet project deliverables while providing technical expertise in a dynamic pharmaceutical clinical labeling environment for Kite Pharma’s global clinical trials.

Internally known as a Labeling Project Coordinator I, this opportunity can be a remotely based position in the contiguous United States and reports to the Senior Manager of Labeling Operations.

Responsibilities of the Clinical Labeling Project Coordinator includes:

• Processes clinical labeling documents and completing activities associated with multiple clinical development programs including, but not limited to, label generation and approval per regulatory guidelines

• Interacts with Kite internal cross-functional teams to provide input into labeling options

• Engages the clinical labeling group to meet company goals including department improvement projects

• Works closely with ancillary groups to process and approve GMP documents

• Authors and reviews documents to ensure GMP compliance.

• Provides responsibility for change control task closures and preliminary assessments

• May participate in other Clinical Supply chain roles

Basic Qualifications:

MS / MA Degree

OR

BS / BA Degree and 2+ years of Packaging / Labeling and/or Project Management experience

OR

Associate Degree and 4+ years of Packaging / Labeling and/or Project Management experience

OR

High School Degree with 5+ years of Packaging / Labeling and/or Project Management experience

Preferred Qualifications:

• Excellent verbal, written, and social communication skills

• Strong computer and organizational skills

• Project and document management experience

• Experience with Change Control is beneficial

• Able to anticipate client obstacles and difficulties and act upon this in order to meet goals

• Ability to write clear, concise and error-free documents

• Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action

• Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13.

• Prior experience with clinical labeling, including the technical aspects of label design, is preferred

Does this sound like you? If so, please apply today!

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