Associate Director, Advertising and Promotional Compliance, US

AstraZeneca•Boston, MA

3d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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