Regulatory Labeling Project Manager
A global pharmaceutical leader, that focuses on solving unmet needs is advertising a vacancy with ProClinical for a Regulatory Labelling Project Manager. The company, whose therapeutics focus is oncology, gastroenterology, and the central nervous system, is seeking for a Regulatory Labelling Project Manager to join their team on a contracted basis; this role will be a 6-month contract that will start-up to a year as needed. They will join the company in their Illinois based team.
The Labelling Project Manager will oversee all activities associated with the development, creation, and execution of labelling for assigned product lines for domestic and/or international markets. They will interact with internal functional groups (e.g. Packaging Development, Quality, Inventory and Planning, and Regulatory Affairs) and third-party suppliers (print vendors, drug product packages). The Labelling Project Manager is the Labelling Operations representative on project teams during the development and approval process of commercial product labelling.
- Maintaining overall responsibility for all creation, revision, and maintenance of labelling material (i.e., artwork and ancillary specification documentation) associated with marketed pharmaceutical products through interactions with advertising agencies, external graphics design studios, print vendors Global Regulatory Labelling, regional artwork suppliers, and international functions as applicable.
- Participating as Labelling Lead on cross-functional project teams.
- Ensuring the control of company printed copy through the approval and distribution of controlled label artwork proofs, printed item specifications, implementation instructions to print vendors, and contract packagers.
- Ensuring technical accuracy and production readiness for all labelling materials associated with assigned product lines and providing back up/overflow support for Labelling team projects.
- Modifying style guidelines for new labelling initiatives due to business model changes or emerging regulatory changes.
- Identifying efficient and continuous improvement opportunities.
- Creating, revising, and approving GMP compliant SOPs to align with new and established policies and procedures.
- Overseeing vendor performance through management of labelling change projects, product launches, and by attending supplier audits and occasional site visits.
- Overseeing and directing proofreading activities in support of labelling projects.
Skills and Requirements:
- A bachelor's degree or 10 years of relevant labelling and/or graphics experience.
- At least 5 years of experience in pharmaceutical label development.
- Strong knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Labelling.
- Strong knowledge of print manufacturing processes and printing graphics techniques.
- Strong knowledge of packaging process and operations.
- Flexibility to manage constantly shifting deadlines, varying deliverables, and communication complexities.
- Excellent communication skills, including fluency in English, persuasion, and inter-personal skills.
- Proficiency with MS Office.
- Excellent analytical skills and judgment with demonstrated ability to manage and interpret complex information from multiple internal and external sources to enable high level decision making.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Cassini on +1 215 531 5288 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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