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Senior Labelling Manager


Location: Remote, New Jersey
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 Senior Labeling Manager:

• The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information and other labeling components) documents for developmental, mature and LCM (life cycle management) products (primarily prescription and non-prescription Consumer Healthcare products) assigned to obtain company and/or agency approval and present to senior management for endorsement.
• Development or update of labeling for these products is based on study results, literature or other information relevant to the product or product class.
• Coordination of labeling review and approval throughout the E2E labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company.
• Coordination of review of local labeling to assure compliance with corporate labeling and participation with affiliates in agency replies for local issues and to assure compliance with corporate labeling.
• Can identify hurdles in implementation and raises them to be addressed.
• Must be able to work with all levels of associates and direct management within the Company (domestic/international), and demonstrate good communication, interpersonal and organizational skills.

Competencies:
• Thorough knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; thorough knowledge of labeling requirements; good organizational skills and strong good ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
• Ability to lead cross-functional teams and able to negotiate, resolve conflict and build consensus.
• Creation and revision of Core, EU and US labeling documents
People Management/Mentorship:
• Provides peer support to other labeling team members and/or vendor oversight on routine labeling projects.

Education:
• Bachelor's degree in Life Sciences or equivalent field or Pharmacy required.
• Master's degree or PharmD preferred.
• Minimum of 5 years Labeling experience

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