Sr. Manager, Global Labeling & Advertising, Pipeline
Global Labeling and Advertising (GLAD), Pipeline Leads are responsible for managing and implementing the regulatory labeling and promotion strategies of new product development projects also known as pipeline projects. The scope of this position includes both drugs and devices and will have direct oversight and accountability for the development of global labeling requirements and content including the establishment of the company core position on safety and efficacy of the compound as well as labeling and promotion activities through launch and during ongoing development. This position will manage interactions with key regions and subject matter experts/stakeholders including regulatory bodies (where applicable) for their assigned portfolio. This position may also be responsible for overall labeling and promotion health by interfacing with other parts of the regulatory organization for their portfolio. This position will be accountable for oversight of effective global implementation of labeling based on regulatory timelines.
Essential Duties and Responsibilities:
· Act as labeling and promotion liaison to other parts of the regulatory organization
· Develop and obtain approval of the company core position on safety and efficacy for the compound (CCDS/CCSI)
· Develop and obtain approval of the target product profile (TPP) for the compound and/or device
· Responsible for setting global labeling and promotion strategy for pipeline projects and documenting it within the global regulatory strategy document
· Utilize technical labeling and promotion regulatory skills in tandem with key SMEs/stakeholders input to collaborate on strategies and develop content that provides solutions to safety or competitive program issues with impact for Baxter
· Responsible for executing labeling and promotion strategies according to plan with successful outcomes for relevant projects
· Responsible for identifying appropriate labeling and promotion standards and content requirements that comply with regulations
· Responsible for providing input into development plans or developing plans related to safety, efficacy and compliance to ensure successful regional registrations (from a labeling and promotion perspective)
· Responsible for alignment of labeling and promotion strategy to business requirements for projects
· Interface and align with other regulatory affairs sub-functions to provide seamless labeling and promotion support to the project team
· Responsible for day-to-day correspondence and interactions with key SMEs/stakeholders and related regulatory agency negotiations
· Represent Baxter externally in industry working groups related to labeling and promotion and provide input into policy decisions and future regulations
· Participate in development and maintenance activities for systems and procedures for pipeline projects
· Adapts regulatory strategies and plans based on changes to regulatory or competitive environment
· Monitor the competitive landscape for the compound/class to provide the most competitively advantageous position for Baxter’s products
· Expert scientific knowledge and ability to apply knowledge in regulatory positioning and planning
· Sound basis of regulatory knowledge, industry norms, and experience with labeling and promotional development
· Demonstrated ability to lead in a matrixed environment
· Strong analytical, project planning, risk identification and problem solving skills.
· Excellent written and verbal communication, presentation, and facilitation skills.
· Excellent interpersonal and negotiation skills (including regulatory authorities) are required.
· Ability to provide strategic and operational guidance across all levels of the company and external vendors.
Education and/or Experience:
· 5-8 years experience in a regulatory function with at least 4 years experience in Labeling and Promotion.
· Bachelor’s degree or country equivalent, in life sciences preferred
· Higher degree will be an advantage.
· International experience/exposure preferred.
· Familiarity with clinical trial protocol development to deliver outcomes favorable to support labeling and promotional claims experience preferred
· Device labeling (including advertising and promotion) experience will be an advantage
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.