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ALMAC Group Project Manager, Label Services in Souderton, Pennsylvania

Almac Group is currently seeking a Project Manager, Label Services for our Souderton, PA location. The Project Manager, Label Services will handle the day-to-day management of all Almac Clinical Services customers. The department coordinates all aspects of the delivery of the project as specified in the quotation. The Project Manager, Label Services will focus on the provision of labels for clinical studies, holding full responsibility for the management, development and provision of approved label proofs suitable for clinical labelling, by coordinating services across Almac departments and external vendors. Responsibilities include but are not limited to: *Possess full knowledge acting as the SME of the extended Label Service process on behalf of all Clinical Services sites and the external vendor partner(s) from concept through to production. *Manage the delivery of labels from contract award to material ready for production (booklets on site or single panel approved proof) to meet project milestones *Develop procedures, tools and best practice documents to support delivery of best in class clinical labels to Almac clients. *Act as the central owner for the generation of all stages of the approved label text. *Liaise with customers, vendor, CROs, label control, PL and internal team to fulfil labelling requests in compliance with local requirements. *Carry out checks based on defined standards such as Annex 13 and US regulations on materials provided. *Provide guidance on clinical labelling requirements to customers and Almac team members. *Carry out documentation prep for customer specific procedures within extended outsourcing agreements. *Coordinate internal and external approvals manually or set up process in LAS *Create and manage workflows for all label stages in LAS *Managing translation of approved label text with a third party translation provider *Investigate all issues related to vendor performance, ensuring timely reports are provided and CAPA identified and agreed. Qualifications: Required Experience / Education: *High School Diploma/GED *A minimum of 2+ years of working experience *A minimum of 1+ year Project management and/or Operational management experience Preferred Experience / Education: *Bachelors degree in Life Sciences or Engineering related discipline *Pharmaceutical and / or clinical supplies industry experience or project management experience within a regulatory environment *Working with external vendors *Working knowledge of the drug development process and clinical trials *Appreciation of regulatory requirements in drug development What Almac Group can offer YOU! *Full medical, vision and dental benefits the 1st of the month after start date *20 days of PTO to start plus 12 holidays per year *Company paid long and short term disability along with life insurance *401k company match *Professional development programs/ continuous learning opportunities

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