Associate Director, US Medical Advertising and Promotions Regulatory - Lexington, United States - Takeda

Description

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The Associate 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. You will be able to provide regulatory strategic oversight for at least one complex product or therapeutic area for assigned US products and/or compounds. You will understand and interpret complex issues in relation to regulatory requirements and promotional strategy.

Purpose:

• Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff.
• You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of proposed promotional and disease state materials.
• You will serve 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.
• Ensures consistent review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
• Supports metrics to measure and track the effectiveness and efficiency of the promotional review process and provides recommendations for process improvements to address potential issues.

Accountabilities:

• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, execute and approve key Commercial campaigns. Provide expert guidance to help evaluate and mitigate potential risk.
• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role thoroughly reviews and assesses proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
• Understand broad concepts within Regulatory Affairs and possible effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
• Provide product development and label development strategies, as needed, to ensure promotional claims can be supported.
• May provide direct supervision of individuals including mentoring, performance management, and staffing decisions. Identify and propose 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.
• 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.
• Leads internal Ad/Promo project workstreams (e.g., best practice documents) and active participant at team staff meetings.
• Collaborates with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences.

Experience/Qualifications:

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Ideal candidate has a minimum of 5 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.
• You will have knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
• Previous experience in Regulatory Affairs promotion and advertising; 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, including representation on global regulatory and labeling teams.
• Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
• You will understand the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
• Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion, including key global codes of practice and regulations. Has 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.

Licenses/Certifications:

• None required. Regulatory Affairs Certification (RAC) desirable.

Travel Requirements:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately up to 25% travel.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.