Associate Director, Advertising and Promotional Compliance

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

• 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

• Participates 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

• Maintains 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

• Works 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

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

• Experience with launching new products and/or new indication

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

• Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms

Desirable Skills/

Experience:

• Advanced degree

• 7 years of relevant experience and/or relevant PharmD…