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Shire Regulatory Affairs US Advertising & Promotion in Lexington, Massachusetts
The US Senior Lead for Regulatory Affairs, Advertising and Promotion (A&P) serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role provides leadership of the Shire electronic approval system (EAS) that supports the A&P review process (Commercial, Medical, Legal, Regulatory; CMLR) and is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Shire policies. Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies expertise to ensure development of promotional and disease state materials are accomplished following the Shire US CMLR process and standards. Establishes and maintains favorable interactions with FDA. Provides direct supervision of individuals including mentoring, performance management, and staffing decisions.
Assists in the development, integration and full implementation of Shire policies in collaboration with the VP Global A&P and the US Head A&P, Lexington (Senior Director). The role serves as the systems expert and will be allocated to other projects as the lead to ensure all are completed as planned. This role will be responsible to lead and manage their direct reports to develop, integrate, implement, and ensure compliance with the US CMLR process and US CMLR Standards.
% of Time
Job Function and Description
Provides expert regulatory evaluation of proposed promotional and disease state materials for assigned products. Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, and assesses consistency of proposed claims with FDA-approved labeling. Serves as the chair of CMLR meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved.
Manages direct reports to ensure consistent review standards within the EAS system are upheld, and business needs are assessed and addressed. Works collaboratively with colleagues in A&P, Medical, Legal, Commercial, and Compliance to achieve alignment. Provides consistent, well-supported, and clear guidance to key stakeholders.
Supports metrics to measure and track the effectiveness and efficiency of the CMLR process, provides recommendations for process improvements to address issues, gains agreement of process improvements from key CMLR-stakeholders, and implements agreed upon process improvements.
Collaborates with the International A&P review teams for materials that are intended for global audiences.
Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of enforcement trends. Participates 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.
Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
Education and Experience Requirements
Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Ideal candidate has a minimum of 7 years’ experience in drug, biologic and/or device regulatory affairs or related field, including a minimum of 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
Demonstrated knowledge of regulations and regulatory guidances specific to advertising and promotion of pharmaceutical/biologic products.
Preferably two (2) years in a team leadership role with highly effective people management skills
Key Skills, Abilities, and Competencies
Expert understanding of FDA regulations and guidances regarding advertising and promotion of prescription drug and biologic products
Significant experience working directly with FDA (OPDP or APLB)
Excellent verbal and written communication skills
Demonstrated interpersonal skills with strong strategic and analytical thinking
Ability to work successfully with a cross-functional team
Ability to work independently, take initiative, and complete tasks to deadlines
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
Listens to and carefully considers others’ perspectives, especially to manage and resolve conflict
Drives accountability and responsibility that enables others to act with integrity
Complexity and Problem Solving
Works with the VP Global A&P, A&P Senior Directors, leaders within A&P, and business partners to identify and resolve issues regarding the acceptability of promotional and disease state programs and tactics. Works with CMLR teams to maintain regulatory compliance while helping to meet commercial objectives. Supports metrics to measure effectiveness of the EAS system, CMLR process, develops recommendations for process improvements, gains endorsement for recommendations, and implements accordingly. Regularly required to exercise good judgment and work effectively in ambiguous situations.
Internal and External Contacts
Internal stakeholders include Commercial, Commercial Operations, Regulatory A&P, Regulatory Affairs, Legal, Medical, Compliance, and Sales Training. External contacts include third-party Commercial Agencies and FDA/OPDP/APLB.
Other Job Requirements
Expected travel: 15%
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.