Clinical Trials Label System Specialist
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).
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
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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
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.