Responsible for the review and oversight of all marketing materials that constitute advertising and promotional activities for US marketed products. Additionally, the management, approval and submission of all advertising and promotional materials to the FDA will be part of this role. Interprets and administers policies, processes and procedures necessary for the approval of marketing materials in collaboration with the marketing unit and the Director of Labeling and Ad Promo. Maintains effective working relationships with legal, Medical Information and Safety, Marketing, and RA Labeling and CMC teams. Supervisory responsibility of direct reports to perform Ad Promo compilation and submission according to FDA regulations.
Review and approve advertising and promotional materials for all US marketed product, including all dosage forms, standard solutions and parenteral nutrition.
Management of animal health and OTC products as dictated by the business.
Oversight includes Ad Promo materials for in licensed products as well as partnership products where FK holds the application but doesn’t market.
Exercise expert judgement 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.
Providing regulatory intelligence and education on emerging regulations and trends in the Advertising and promotional space. Provides comments and perspective on proposed regulations.
Anticipates changes in the regulatory environment and the potential impact to FK, 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 ensure timely and complete submissions.
Monitor labeling safety changes to ensure current FK labeling is up to date prior to submission.
Monitoring of FDA website for RLD label changes and notification of impacted products as necessary to support overall FK compliance.
Strategically lead the transition from paper to electronic submission format.
Helps staff to interpret changing priorities, processes and requirements.
Leads the development of procedures or tools to increase work efficiency.
Translates strategic goals into group and individual performance objectives
Motivates and encourages by recognizing accomplishments and providing feedback
•Bachelor degree in life sciences / medical discipline. •5 plus years related experience in the pharmaceutical industry with 3 to 4 years of regulatory affairs experience including advertising and promotional responsibilities. •Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to advertising and promotional materials. •Demonstrated effective oral and verbal communication skills, attention to detail, and superior organization skills •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, disabilities, or protected veteran status.
Internal Number: LZP00709
About Fresenius Kabi USA, LLC
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.