The Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness, and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review, and approval of promotional materials. Additionally, the Director will act as the primary liaison with the FDA on ad/promo regulatory issues concerning promotional materials.
Accountabilities- Reviewing US promotional and non-promotional/scientific material, attending review meetings, and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations, advertising, promotion, and communication as applicable.
- Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253, and materials submitted for advisory comments.
- Participating in developing processes and procedures relevant to the creation, review, and approval of advertising and promotional materials: Developing standard processes, working instructions, and/or SOPs to establish standards and consistency across company brands.
- Providing training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific congresses and conferences.
- Advising product development teams on advertising and promotion issues to facilitate the strategic development of new products.
- - Maintaining regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars. Presenting new regulatory standards pertaining to drug promotion to brand teams and management, as appropriate.
- Participating and supporting ongoing key initiatives including the development, implementation, and continued improvement of new promotional review processes.
- Supporting and mentoring ad/promo colleagues.
Essential Skills/Experience- Bachelors Degree
- 7 years pharmaceutical industry in regulatory affairs and/or advertising and promotion compliance
- Expertise in US advertising and promotional regulations and current regulatory environment
- Experience communicating and negotiating directly with OPDP and/or APLB
- Experience managing a team or having direct reports
- Experience with global standards for advertising and promotion compliance
- Proven record practicing good judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Proficiency using Microsoft Office software and promotional review software, such as Veeva Promomats and Veeva Medcomms
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable Skills/Experience- JD, PharmD or master's degree
- Excellent written and verbal skills
- Strong interpersonal, communication, and leadership skills
- 10 years pharmaceutical industry in regulatory affairs and/or advertising and promotion compliance
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Joining Alexion means embracing an opportunity where work isn't ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit - we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. Supported by exceptional leaders and peers ready to lift you in marketing, compliance, and beyond.
Ready to make a difference? Apply now!
Date Posted21-Nov-2024
Closing Date06-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations[redacted] Alexion participates in E-Verify.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
