US-MA, Director, US Medical Ad/Promo Regulatory R0013068-MZ
Title:Director, US Medical Ad/Promo Regulatory
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, US Medical Ad/Promo Regulatory, in our Lexington office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Director, US Medical Ad/Promo Regulatory, you will be empowered to make strategic decisions that will support development of compelling and compliant promotional materials. In this role, you will contribute to Takeda s mission by ensuring the right information is provided to the right customer.
The Director, US Medical Ad/Promo Regulatory 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 promotional review process for at least one (1) business unit/ therapeutic area and is responsible for thoroughly assessing proposed promotional strategies/materials to evaluate feasibility, risk assessment and compliance with regulatory requirements and internal policies and procedures.
Assists in the development, integration, and full implementation of internal policies, in collaboration with US Medical Ad/Promo Regulatory Senior Leadership.
The role serves as the process expert and is the lead for applicable Ad/Promo projects to ensure collaboration with key stakeholders and completion as planned.
Provides direct supervision of individuals including mentoring, performance management, and staffing decisions. This role will be responsible for leading and managing direct reports.
Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards.
Establishes and maintains favorable interactions with FDA.
Collaborates with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences.
Provides overall Ad/Promo Regulatory leadership, strategic guidance, and expert regulatory evaluation of proposed critical promotional materials for products within assigned business unit/therapeutic area.
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 that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders.
Serves as the chair of promotional review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
Provides expert guidance related to Regulatory strategy to senior Commercial leadership and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
Participates in promotional review meetings to resolve potential issues and participates in escalation meetings, as needed.
Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of FDA enforcement trends.
Represents US Medical Ad/Promo Regulatory on organizational or business unit initiatives (e.g., digital medial council, FDAMA 114 committee, revisions to promotional standards).
Manages direct reports to ensure consistent review standards within the electronic approval system (EAS) system are upheld, and business trends are evaluated and addressed.
Supports metrics to measure and track effectiveness and efficiency of the promotional review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements.
Collaborates with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
Participates in the 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 the use of claims for assigned business unit/therapeutic areas.
Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
Provides direct supervision of individuals including mentoring, performance management, and staffing decisions. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
Presents to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
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 4 years experience specific to Regulatory Affairs Advertising and Promotion. Candidates with experience in related fields may also be considered.
Extensive knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
Extensive experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
Provide leadership related to issues of critical importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes of practice and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders.
Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership.
Prior leadership of individuals/team preferred.
Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives.
Models leadership at all levels daily.
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately up to 25% travel
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
Discover more at takedajobs.com
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