Senior Manager, US Medical Ad/Promo Regulatory応募 後で応募 求人ID R0013936 掲載日 01/09/2020 Location:Lexington, Massachusetts
- The Senior Manager, 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.
- Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds. Position will primarily support review of Patient Services and Corporate materials across different business units, including additional product responsibilities.
- Understands and interprets complex issues in relation to regulatory requirements and promotional strategy.
- Mentor and help develop staff. Assists with training and sharing technical and regulatory guidance to staff.
- Serves as the chair of promotional review meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- May present to senior management, and/or present regulatory topics to cross-functional teams.
- May 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.
- Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies Regulatory knowledge to ensure promotional and non-promotional material development is accomplished following internal processes and standards.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
- Understands broad concepts within Regulatory Affairs and potential implications across the organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Evaluates regulatory risks and makes recommendations relative to the overall promotional strategy.
- May provide direct supervision of individuals including mentoring, performance management, and staffing decisions. Able to mentor and develop staff. 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.
- 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).
- 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 4 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 2 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 guidance specific to advertising and promotion of pharmaceutical/biologic products.
- Experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) preferred.
- Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Ability to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
- Understands the phases, processes and techniques used within a clinical development environment, and can contribute to clinical study design discussions, as needed.
- Maintains 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 not required, but preferred.
- Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives.
- Models leaders at all levels daily.
None required. Regulatory Affairs Certification (RAC) desirable.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately up to 20% travel