Label Project Coordinator

Hobson Prior is seeking a Label Project Coordinator to join a dedicated team. This role will be responsible to read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software. The successful candidate will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems.

Primary Activities:
Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate safety requirements to meet exacting standards defined by the company, the FDA and EU or other international regulatory agencies.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Coordination of translation requests.
• Generation of clinical label proofs with CLPG.
• Liaise with country-level clinical operations personnel or regulatory affairs to address questions, revise translations, update regulatory requirements, etc.
• Maintain label translations library.
• Interpret clinical study design and clinical supply strategy (CSS).
• Design and verify label models.
• Coordinate MLBL manufacturing with vendors.
• Perform visual inspection and accountability for label proofs, clinical labels and RCE's.
• Provide detailed analysis of issues and collaborate for creative problem solving.
• Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or?other stakeholders.
• May represent Clinical Packaging on internal or cross-functional teams. Will undertake specific projects within the group on as needed basis.
• Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate?Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.
• Train and remain proficient in appropriate systems and software.
• Responsible for the physical facility and good housekeeping practices within their area.

Key Skills and Requirements:

• BS/BA or relevant education and relevant practical experience.
• Working knowledge of Packaging Operations and related work centers.
• Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution.
• Strong attention to detail.
• Strong verbal and written communication skills.
• Strong organizational skills, ability to prioritize and ability to multi-task.
• Knowledge of general computer skills (i.e., MS Word, Excel, PowerPoint).
• German speaking advantageous.

For more information, please contact Chad Petersen.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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