Director, Advertising and Promotional Compliance, US
Director, Advertising and Promotional Compliance, US
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Job Description
Introduction to role
The Director Advertising and Promotional Compliance US will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. 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 material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials.
Accountabilities
- Reviewing US promotional non-promotional and scientific material attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to compliance standards and FDA regulations pertaining to prescription drug 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
- Developing processes and procedures relevant to the creation review and approval of advertising and promotional materials: Developing best practices working instructions and/or SOPs to establish standards and consistency across company brands
- As needed providing training support within Alexion on 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 and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management as appropriate
- Participating in and supporting ongoing key initiatives including the development implementation and continued improvement of promotional review process
- Supporting and mentoring ad/promo colleagues
Essential Skills/Experience
- Bachelors degree
- 7 years pharmaceutical industry in regulatory affairs and/or advertising and promotion
- Expertise in US advertising and promotional regulations and the current regulatory environment
- Experience communicating and negotiating directly with OPDP and/or APLB
- Experience leading a team or experience having direct reports
- Experience with global standards for advertising and promotional compliance
- Excellent written and verbal skills and strong interpersonal skills
- Consistent track record practicing sound 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
- Strong interpersonal communication and leadership skills!
- 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 masters degree preferred
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin sex gender gender expression sexual orientation age marital status veteran status or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 isnt ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to 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 vibe entrepreneurial spirit and autonomy of a leading biotech. Youll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team youll meet 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 patients journeys. Youre supported by exceptional leaders ready to lift you in marketing compliance and beyond. Make an impact means motivating change with integrity supported by a culture that celebrates diversity innovation and connection to patients lived experiences.
If this sounds like a team you want to be part of... then wed love to talk.
Date Posted
23-May-2025Closing Date
05-Jun-2025Alexion 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 Alexion participates in E-Verify.Required Experience:
Director
Employment Type
Full-Time
