Associate Director, Advertising and Promotional Compliance, US at Alexion in Boston, Massachusetts

Job Description:

The Associate 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 Associate 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. The Associate Director may also act as the primary liaison with 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 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, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253


• As needed, 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 conferences


• In collaboration with their manager, providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products


• Ensuring stakeholder awareness of proposed and newly approved labeling changes


• Informing, reviewing, and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner


• In collaboration with their manager and the Medical Legal Regulatory (MLR) Coordinator, participating in developing processes and procedures relevant to the creation, review, and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company 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. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate


• Working with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders


• Collaborate with ad/promo team and Reg Ops on creation and implementation of novel submission processes


• Participating/assisting in US labeling negotiations and FDA meetings as necessary

Essential Skills/Experience:

• Bachelor's Degree


• 5 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience


• Knowledge of U.S. advertising and promotional regulations


• Experience communicating and negotiating directly with OPDP and/or APLB


• Experience with global standards for advertising and promotion compliance


• Knowledgeable on industry compliance requirements and non-compliance examples and trends


• Demonstrated ability to influence others and foster team collaboration


• Experience with launching new products and/or new indication


• Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate


• Solid understanding of business goals and common marketing concepts/tools, including the internet and social media


• 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:

• Advanced degree


• 7 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience


• History having direct reports or mentoring junior team members


• Proven track record practicing sound judgment as it relates to risk assessment


• Strong interpersonal, communication, and leadership skills


• Proven ability to prioritize and meet critical business timelines

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 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. You'll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you'll be 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. You're supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.


Ready to make a difference? Apply now!



Date Posted

09-Jan-2025



Closing Date

14-Jan-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 accommodations@Alexion.com. Alexion participates in E-Verify. Apply Now