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Almac Group · 1 day ago

Project Lead - Labels

Durham, NC

Full-time

Onsite

Mid Level

4+ years exp

Almac Group is a company focused on enhancing human health globally, and they are seeking a Project Lead - Labels to drive and execute the development of clinical labels and related materials. This role involves managing timelines, customer relationships, and internal teams throughout the clinical label lifecycle, ensuring compliance and timely delivery of labels.

BiotechnologyHealth CareManufacturingPharmaceutical

Responsibilities

Drive the completion of all master text, translation, regulatory review, design, proofing, and generation of labels for production activities with the appropriate operations group including 3rd party vendors necessary to ensure timely and efficient delivery of labels, ensuring full compliance with current Good Manufacturing Practice

Serve as the primary contact and subject matter expert to the customer and Clinical Supply Manager for Label development activities, communicating status, issues, questions, and outstanding information to the internal and external team

Develop strategies to successfully deliver labels and advise the customer and CSM of any issues or delays arising throughout the course of the project, identifying and resolving issues prior to patient or study impact, as appropriate, ensuring internal issues have been resolved effectively in collaboration with internal project team colleagues and stakeholders

Review and approve information/documentation required for the management of labels required for production

Direct the activities of Project Label Coordinators as required, ensuring timelines and deliverables are achieved

Provide feedback as required

Ensure the scope of the quote is understood and any out-of-scope activities requested are highlighted to the CSM as needed for quote updates or to BD directly using the scope change process when no CSM is assigned

Liaise with other departments and business units at all sites as required, to control the project, resolve problems and escalate issues

Solve label related issues, ensuring high customer service levels

Take ownership, demonstrate accountability, foster synergy, exhibit professionalism, and urgency in issue resolution

Hold full responsibility for the management of projects involving label activities only when no Clinical Supply Manager is assigned

Serve as the primary point of contact for the customer and CSM as applicable

Exercise good judgement and informed decision making, both on behalf of the customer and in the best interest of Almac