Bayer Global Labeling Manager in Whippany, NJ, New Jersey
Your tasks and responsibilities
Position Purpose: The primary responsibilities of this role, Global Labeling Manager are; • Lead the end-to-end process for creating, maintaining, communicating and implementing core product information on a global basis and for managing the review and approval process for local deviations or exceptions; • Generation, implementation and management of product specific Company Core Data Sheets (for development and marketed products) and Company Patient Information in order to present all important data in a comprehensible form and to enable countries to produce prescribing information for health care professionals and for patient information in accordance with local/regional legal and regulatory requirements; • Steer and maintain process for global texts of registered/marketed products (Change Management); • Steer Product Evaluation Teams (PET); • Manage implementation of labelling changes in the countries; • Ensures coordinated label implementation with manufacturing following; • HA approvals and directs batch destruction/recall when needed; • Ensures consistency among global labeling documents and compliance with global labeling standards and relevant regulatory requirements; • Controls changes in regulatory environment regarding legal requirements and guidelines for Labelling. Takes the changes pro-actively up and influences them in the environment; • Create and maintain global labeling standards; • Supports and trains experts, regional functions and affiliates with regard to labeling topics; • Serve as liaison with business partners on all matters related to labeling and ensure that necessary processes are in place to maintain consistency and quality of labels for products which are co-licensed, co-marketed or co-promoted. Ensures appropriate and timely revisions to label with respect to safety.
Who you are
Qualifications: • Requires a PhD, PharmD or MD, preferably in life sciences, with 6 or more years’ experience in the labeling field of which 4 years are in the pharmaceutical industry (preferably within development functions). Or MS degree with 8 or more years’ experience in the labeling field of which 4 years are in the pharmaceutical industry or BS or BA degree with 10 or more years’ experience in the labeling field of which 6 years are in the pharmaceutical industry; • Expert knowledge of legal regulatory requirements and compliance is required; • Scientific/technical expert knowledge is required; • Excellent project management and communication skills.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled