Manager, Global Advertising and Promotional Compliance

Alexion Pharmaceuticals, Inc. Boston, MA
Position Summary

The Manager, Global Labeling, Advertising and Promotional Compliance serves as the Regulatory Affairs (RA) representative on product promotion review teams. The 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 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 Manager also acts as the primary liaison with FDA 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 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

Preferred Qualifications

* JD, PharmD or Master's Degree preferred

* LI-JD1

Boston, MA, United States

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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion 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). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

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.

As a leading employer in our industry, Alexion is proud to offer 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, relocation assistance and much more. To learn more about Alexion, please visit www.alexion.com.

Alexion is an Equal Opportunity /Affirmative action employer