Project Lead - Labels

Project Lead - Labels

The Project Lead – Labels will main objective is to successfully drive and execute the development requirements of clinical labels and other published material per customer requirements at any Almac Clinical Services Site. This includes communicating and driving timelines both internally and externally and managing the internal teams as well as the customer relationship throughout the Clinical Label lifecycle from Protocol to Label Proof Design.

The exact tasks performed for any given project are based upon the services quoted.

• 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 to ensure timely and efficient delivery of labels, ensuring full compliance with current Good Manufacturing Practice. Assume ownership for the delivery of label development and customer service deliverables related to label activities.
• 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.

• HS diploma with 4+ years relevant work experience or Associates Degree with 1+ years Project Management and/or Operational experience

• Bachelor's Degree in Science or business‑related field highly preferred
• Pharmaceutical or clinical supplies industry experience
• Project management experience within a manufacturing environment
• Customer service/client relations
• Work overtime when and where required
• Communication proficiency

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Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

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