Sr Manager, Regulatory Advertising & Promotions
Job Summary
The Senior Manager, Regulatory Advertising and Promotions (Biosimilar) position is responsible for the review and oversight of all marketing and sales training materials that constitute advertising and promotional activities for US Biosimilar marketed products.
The position is responsible for the management, of timely submissions of all advertising and promotional materials to the FDA.
Interprets and administers policies, processes and procedures necessary for the review and approval of marketing and sales training materials in collaboration with the market unit.
Maintains effective working relationships with legal, Medical Information and Safety, Marketing, and RA teams. Participates in management discussions, provides strategic guidance including supervisory responsibility of any direct reports for Ad Promo review, compilation and submission according to FDA regulations.
The ideal candidate will work hybrid out of our Lake Zurich, Illinois corporate office. Qualified candidates remote to the area will also be considered.
Responsibilities
Review and approve advertising and promotional materials, corporate and other non-promotional materials as applicable, for all US marketed products-primarily Biosimilars;
support other pharmaceutical drug products as needed.
- Oversight could also include AdPromo materials for in licensed products as well as partnership products where Fresenius Kabi holds the application but doesn’t market.
- Responsible for operational leadership to ensure compliance with current FDA regulations and expectations and consistency in regulatory decisions concerning marketing materials.
Decisions include appropriateness of materials, amount of safety information, eligibility for submission, bundled strategies, multimedia materials, etc.
- Assume a leadership role in advising cross-functional stakeholders on the regulatory impact of new campaign concepts and may also be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications
- Develop regulatory strategy and Fresenius Kabi philosophy around advertising and promotional materials for biosimilar products.
- Providing regulatory intelligence and education on emerging regulations and trends in the Advertising and promotional space including reviewing and interpreting enforcement letters specifically for biosimilar products.
- Provides comments and perspective on proposed regulations.
- Anticipates changes in the regulatory environment and the potential impact to Fresenius Kabi, shaping internal strategies accordingly
- Influence and obtain buy-in from peers and co-workers when reviewing and approving materials.
- Prioritize workload based on the Marketing unit needs and work together with the technical submissions manager to ensure timely and complete submissions.
- Develop process for tracking of OPDP submissions to improve operational efficiency and potentially reduce review time on future materials
- Managing and prioritizing the team's workload in accordance with departmental goals
- Helps staff to interpret changing priorities, processes and requirements,
- Leads the development of procedure or tools to increase work efficiencies
- Anticipate peak workloads and resource accordingly
- May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
- Motivating staff and maintaining the team's focus on departmental objectives
- Translates strategic goals into group and individual performance objectives
- Motivates and encourages by recognizing accomplishments and providing feedback
Requirements
- Bachelor’s degree in life sciences / medical discipline.
- 6 or more years related experience in the pharmaceutical industry, including but not limited to regulatory affairs experience.
People Management experience a plus
- 4 plus years’ experience in US regulatory affairs advertising and promotional review
- Thorough understanding of US regulations for drug promotion / advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches for biologic / biosimilar products.
- Demonstrated effective written and verbal communication skills, attention to detail, and superior organization skills
- Demonstrated experience in working with others collaboratively to achieve organizational objectives including the ability to lead and influence decisions, anticipate and adapt, work tactics to support changing business needs
- Proven ability to analyze and interpret efficacy and safety data
- Proficient in standard business software applications and an aptitude for electronic systems and software.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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