Job Detail

Senior Manager, Advertising & Promotional Compliance

Req ID: 15219
Job Category: Regulatory Affairs

Location: Zurich, Zurich

Posting Date: January 18, 2019

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We are looking for: Senior Manager, Advertising & Promotional Compliance

Location:Zürich, London or Paris

Position Summary

The Senior Manager, Global Advertising and Promotional Compliance serves as the Regulatory Affairs (RA) representative on product promotion review teams. The Senior Manager 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 Senior Manager will engages 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 Senior Manager also acts as the primary liaison with FDA and other global regulatory agencies on regulatory issues concerning promotional materials.
 

Job Duties & Responsibilities

• Reviews global and US promotional, disease awareness, public affairs and medical materials, 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


• Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253


• As needed, provides 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, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products


• Ensures stakeholder awareness of proposed and newly approved labeling changes


• Provide guidance to (G)MLR to ensure  appropriate implementation and reflected in assigned product ISIs and promotional materials in a timely manner


• In collaboration with their manager in the Global Advertising and Promotional Compliance group and (G)MLR Coordinator, participate 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

   

  Essential Qualifications

• Bachelor Degree


• 3 -5 years of relevant experience or relevant PharmD post-doctoral Fellowship experience


• Solid knowledge of European and/or U.S. advertising and promotional regulations


• Direct experience communicating and negotiating directly with OPDP


• 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


• Fluency in English is required, knowledge of other European languages is a plus

   

  Preferred Qualifications

• JD, PharmD or Master’s Degree preferred

Zurich, Switzerland
 

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.