Catalent Pharma Solutions Clinical Trials Label System Specialist - Clinicopia in Kansas City, Missouri

Job Description

Clinical Trials Label System Specialist

Position Summary:

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8

The Clinical Trials Label System Specialist is a critical position in the success of vital clinical trials all over the world. This position makes a huge impact in Patient Safety for hundreds of clinical trials per year.

The Clinical Trials Label System Specialist provides support to the internal and external customers by designing kit structures, setting up protocols, completing print requests, managing customer randomizations for use in clinical and commercial packaging and distribution in addition to many other tasks.

This role is the go-to person for any and all questions related to Clinicopia. Responsibilities are carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

The Role:

  • Responsible for kit structure design, setting up model protocols, orderable kits, work orders, and randomization setup in Clinicopia.

  • Label Print request creation and approval within Clinicopia utilizing scope documents. Also provide regulatory audit and client audit support.

  • Documentation and paperwork management. Complete and understand all paperwork that is used for the creation, printing and inspection of labels.

  • Knowledge of label regulatory requirements and an understanding of where to verify answers. Comfortable interacting with client representatives. The knowledge to communicate suggestions while understanding their need. Educating others in an effective manner.

  • Subject Matter Expert for any and all issues related to label control Clinicopia.

  • Assist with enforcing the master schedule with a commitment to hitting On Time Delivery (OTD). Prioritize self with a big picture of the team. Promote team work where necessary to accomplish tasks.

The Candidate (requirements)

  • High School Diploma or Equivalent required. Business or Computer Degree recommended.

  • 5-7 years of clinical labelling experience or related pharmaceutical operations experience preferred.

  • Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel. Computer/Technical experience strongly recommended.

  • Demonstrate a bias toward action. Get things done. Be willing to take a position and assert influence to drive improvement. Foster teamwork to get results.

We will identify candidates based on the following:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organization with a people focused culture

  • Global exposure, defined career path and annual performance review and feedback process

  • Competitive Medical, Dental, Vision and 401K

About Catalent

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.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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 Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.