Job Vacancy Associate Director, Global Advertising and Promotional Compliance Alexion Pharmaceuticals

Job title: Associate Director, Global Advertising and Promotional Compliance

Company: Alexion Pharmaceuticals

Job description: Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Associate Director, Global Advertising and Promotional Compliance serves as the Regulatory Affairs (RA) representative on assigned product promotion and medical review teams. The Associate Director has responsibility for reviewing and approving the regulatory content of global and US materials created for product promotion, disease awareness and public affairs communications. The Associate Director will 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, as well as other promotional procedural documents including, but not limited to label/ISI updates, inventory destruction, etc. The Associate Director will also play a critical role in the continual assessment of the Veeva review platform and provide feedback as needed to better optimize the system for the regulatory reviewer. The Associate Director also acts as the primary liaison with FDA on regulatory issues concerning promotional materials.

You will be responsible for:

  • Reviewing global and US promotional, disease awareness, public affairs, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
  • Reviewing global and US medical materials and attend medical review meetings and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to scientific exchange, as applicable
  • Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and 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 in the Global Advertising and Promotional Compliance group, 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 in the Global Advertising and Promotional Compliance group and Global Medical Legal Regulatory ([G]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
  • In collaboration with the Ad/Promo team, monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, Enforcement Actions published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings; the role will also work 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
  • Collaborating with Ad/Promo team and Reg Ops on implementation and roll-out of electronic Common Technical Document (eCTD) for OPDP and APLB submissions
  • Participating/assisting in US labeling negotiations and FDA meetings as necessary

You will need to have:

  • Bachelor’s Degree
  • JD, PharmD or master’s degree preferred
  • 5 -7 years of relevant experience or relevant PharmD post-doctoral Fellowship experience
  • Solid knowledge of U.S. advertising and promotional regulations
  • Direct experience communicating and negotiating directly with OPDP and APLB
  • Experience with global standards for advertising and promotion compliance
  • Proven 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
  • Proven ability to prioritize and meet critical business timelines
  • 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
  • Knowledgeable on industry compliance requirements and non-compliance examples and trends
  • 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.


Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .

Alexion 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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion’s COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact . Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, click .

Expected salary:

Location: Boston, MA

Job date: Sat, 11 Jun 2022 22:54:24 GMT

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