Clinical Labeling Support Specialist

Job Description

• Supports the creation, transfer, review, and coordination of clinical labels for clinical supplies used in clinical studies.
• Transfer clinical labels into a new system
• Create and design clinical labels according to established requirements
• Proofread label proofs to ensure accuracy and compliance
• Coordinate labeling documentation and related approvals
• Support additional labeling-related projects as needed
• Manage assigned labels and studies independently
• Create labels using source documents and global regulatory requirements, ensuring information is complete, consistent, and accurate
• Communicate and coordinate labeling and documentation activities with worldwide affiliates
• Maintain professional communication with internal business partners and global stakeholders
  
  

Qualifications

• High school diploma or equivalent; OR
• BA/BS degree preferred in Science, English, Business or related field
• Proficient computer skills and ability to quickly learn new software and systems
• Data entry experience with a high degree of accuracy
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills
• Ability to work independently with minimal supervision
• Ability to collaborate effectively as part of a team
• Strong time management skills and ability to manage multiple priorities
• Comfortable working in a highly regulated environment
• Able to follow detailed instructions and established procedures
• Flexible and responsive to changing priorities and business needs
• Strong computer proficiency, and the ability to quickly learn and apply new systems and processes.
• Dependable, self-motivated, able to work independently, and also function effectively as part of a team.
• Ability to adjust priorities on short notice in response to changing business needs is critical.
• Excel and design programs (adobe) experience will be helpful.
• Clinical labeling experience is preferred
• GMP (Good Manufacturing Practices) knowledge and proofreading experience.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.