Clinical Trial Label Associate

Organization

Clinigen Group is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world. We are the global leading experts, trusted by both pharmaceutical and biotech companies and healthcare professionals, in providing access to medicines throughout the lifecycle of a medicine; clinical trials, unlicensed and commercial supply. Operating in a complex regulatory environment, Clinigen is the only company to globally manage access to medicine across all three routes worldwide.

We are currently 1000 people, headquartered in the UK, with global offices in the US, Japan, Asia Pacific, South Africa, and across Europe. Our mission is to deliver the right medicine to the right patient at the right time and to help achieve this, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

Job Profile:

This position is responsible for production of specialized labels for use on client specific projects for clinical trials and to provide support in the Operations Department with a variety of professional assignments. 

Key Responsibilities:

• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

• Produces clinical trial labels from approved label text proofs using the tabletop thermal transfer printer and associated software 

• Accurate and timely completion and filing of required paperwork  

• Maintain and receive clinical label inventory within Clinigen CSM’s inventory management system 

• Actively update At Task following the completion of each labeling activity 

• Generates print randomizations from client kit lists 

• Responsible for communicating operational and personal concerns as well as opportunities for improvement to the department leadership 

• Actively pursues education to become proficient with GMP’s as they relate to printing and handling of clinical trial labels 

• Takes responsibility for personal skill development in continuing to learn current pharmaceutical standards and industry trends 

• Learns and adheres to Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and CSM’s Standard Operating Procedures (SOPs) 

• Perform other related job duties or responsibilities as assigned 

Role Requirements:

• High School Diploma or GED

• 1 year of related work experience in an office setting 

• Familiar with the tools, concepts, and methodologies of label design (graphics) and printing desired 

• Preferred experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP) 

• Ability to work independently or within a team  

• Detail oriented to produce timely and accurate work 

• Excellent oral, written, and interpersonal communication skills with active listening ability 

• Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast paced environment 

• Maintain a high regard for confidentiality while dealing with all clients, proprietary, and pharmaceutical related information  

• Highly computer literate; experience operating with all Microsoft Office software

• Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines), including Tabletop Thermal Transfer Printer and associated software

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
Masks are required onsite.

Application Question(s):

• What are your salary requirements?

Experience:

• Warehouse: 1 year (Preferred)
• Office setting: 1 year (Preferred)

Work Location: One location