Director, US Advertising and Promotional Compliance

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!

Desirable Skills/Experience:

• JD PharmD or masters degree preferred

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -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 individualflexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here scientists strategists and storytellers come together to ensure our communications reflect the same integrity and ambition as our science. We operate with the focus of a nimble biotech and the reach of a global biopharma bringing unexpected teams together to spark bold thinking that turns complex biology into meaningful patient impact. You will grow alongside leaders who value kindness as much as high standards work with cutting-edge therapies addressing serious unmet needs and see your decisions directly shape how transformative medicines reach those who need them most.

Own the standard for US promotional compliance and help bring breakthrough therapies to patients with clarity and integritytake your next step with us today.

The annual base pay for this position ranges from $193281 to $289922 . Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.