Alexion Pharmaceuticals Senior Director, Advertising & Promotion Compliance in Boston, Massachusetts
The Senior Director, Advertising and Promotion (“A&P”) Compliance will direct and conduct the regulatory affairs aspects of review and approval of promotional materials and marketing activities for all products in the Alexion portfolio and pipeline, including acquisition products. This individual will have primary responsibility for strategic planning and preparation of critical submission documentation with business partners and the U.S. Food and Drug Administration (“FDA”). S/he will lead and direct the Regulatory Affairs Advertising and Promotion review organization in support of the Alexion portfolio, pipeline and therapeutic areas, and will develop and implement strategies to facilitate the development and review of promotional materials and activities. This is a leadership role in regulatory affairs interacting with commercial, medical and legal on a regular basis with very strong interactions occurring when in launch mode.
Job Duties & Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drugs.
In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling.
Provide regulatory leadership to the respective cross-functional team charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with FDA regulations and Company policies
Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Alexion policies; review and revise regulatory policies to ensure compliance with FDA requirements.
Contribute to the modification, development and implementation of Company practices and policies for advertising and promotional activities.
Assist Commercial with the planning and prioritization of proposed promotional and disease state materials; provide expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved.
Serve as a member of the Medical Review Committee to ensure regulatory compliance for non-branded, diseases specific or investigational drug communications.
Maintain a thorough understanding of the Office of Prescription Drug Promotion (“OPDP”) requirements, as well as a keen awareness of enforcement trends. Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials or materials requiring pre-clearance such as products under Subpart H or Subpart E approval.
Participate in the preparation and review of comments to FDA’s docket regarding Federal Register Notices that may impact the organization’s promotion of commercial products.
Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253.
In collaboration with global regulatory operations, ensure the management and maintenance of records and databases that support communication with OPDP.
Provide consistent, well-supported, and clear guidance to key stakeholders.
Deliver Regulatory compliance training to assigned teams in preparation for scientific conferences on and off site.
Participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials.
Collaborate with global regulatory operations and cross-functional colleagues to assess and optimize use of electronic review and archiving tools.
Provide input, review and approve web-based materials.
Identify and escalate any unresolved regulatory affairs compliance concerns to the Vice President, Global Regulatory Affairs and/or the Senior Vice President, Regulatory Affairs & Patient Safety.
Bachelors Degree is required
7-10 years’ of relevant industry experience which shall include demonstrated regulatory affairs experience specific to Advertising and Promotion Compliance is required
Expert understanding of FDA regulations and guidelines specific to advertising and promotion of pharmaceutical products is required;
Significant experience communicating and negotiating directly with the OPDP.
A solutions-driven mindset with the ability to transform a requirement into a proposal and to be perceived as a constructive colleague who helps state ideas at the outset.
A highly collaborative mindset; self aware, emotionally intelligent and a good listener open to ideas and an exchange of meaningful dialogue with peers. Ability to listen to and carefully consider others’ perspectives and to manage and resolve conflict.
A proven track record of 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.
Ability to work in a fast-paced environment and to manage multiple competing tasks and demands.
Forward thinker with strong industry knowledge and ability to identify, synthesize and act upon strategic information and changes within the environment.
Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.
Demonstrated decision-making and problem solving capability; ability to negotiate skillfully to achieve a fair outcome or promote a common cause.
Demonstrated ability to represent Alexion’s interests, objectives and policies in a professional and responsible manner.
Advanced degree (JD, PharmD or Master's Degree) is preferred
Labeling experience is not required but will be a plus.
Rare diseases experience is preferred.
Knowledge of global regulations for advertising and promotion compliance is strongly preferred.
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer