Label Coordinator

Responsibilities: 

· Establish translation and label requirements for new studies.

· Generate and manage timelines and project milestones to ensure client delivery date can be achieved.

· Co-ordinate the transfer of information between translation supplier, client, Label Room, and Project Management.

· Co-ordinate the proofing process between the external label supplier, CTS and the client.

· Liase with client and/or local country affiliates to attain label text/label proof approval.

· Review of text and/or label proofs to ensure all requirements/amendments have been incorporated.

· Maintain detailed spreadsheets for tracking approval status.

· Track and record amendments/errors in label text/proofs.

· Version control of all text, labels and approvals.

· Provide regular status reports on each project minimally during Operations and Project Review Meeting.

· Generation and review of SOPs associated with text approval process.

· Generate and maintain a database of country specific label text requirements.

· Responsible for timely and accurate generation and review of Quality Incidents, Technical Queries and audit responses pertaining to label activities.

· Responsible for label coordination activities in client visits and audits.

· Identify, develop and implement systems and procedures to allow CTS to offer clients improved label services.

· Review and update all Standard Operating Procedures involving label coordination in line with cGMP’s and approved changes to practice.· Bachelor Degree· Ability to lift 20 pounds· Clinical trial experience, clinical label experience preferred· Excellent verbal and written communication skills· Excellent computer skills· Attention to detail · Works well alone and with others in a team environment · Ability to work outside normal business hours and weekends (if needed) . 

Successfully passing a drug screen, employment, education, & criminal background checks.

Candidates debarred/prohibited from employment in the pharmaceutical industry under the Generic Drug Enforcement Act of 1992 are not eligible for employment with Almac.

External candidates must provide salary requirements for consideration. No relocation or interview travel expenses available.