Associate Director, Advertising and Promotional Compliance, US Job at Alexion Ph

Associate Director, Advertising and Promotional Compliance, US

The Associate 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

• Review US promotional, non‑promotional, and scientific material, attend review meetings and provide 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.
• Serve as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products.
• Develop processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices, working instructions and/or SOPs to establish standards and consistency across company brands.
• Provide 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.
• Advise product development teams on advertising and promotion issues to facilitate the strategic development of new products.
• Maintain regulatory expertise in product promotion and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars, and communicate new regulatory standards to brand teams and management as appropriate.
• Participate in and support ongoing key initiatives including the development, implementation, and continued improvement of promotional review process.
• Support and mentor ad/promo colleagues.

Essential Skills/Experience

• Bachelor’s degree.
• 3+ years pharmaceutical industry experience 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 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 and promotional review software such as Veeva Promomats and Veeva Medcomms.
• Ability to work in an office environment, using a computer, phone, video, and electronic messaging; analyze, collaborate, and maintain availability during standard business hours.

Desirable Skills/Experience

• JD, PharmD or master’s 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.