Sr. Director, Regulatory Advertising and Promotion Policy
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham Posted Date: Jun 16 2021 Senior Director, Team Lead, Regulatory Advertising and Promotion Policy Location: USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence, USA - Pennsylvania - Philadelphia Site-based preferred. Remote-based position will be considered. Must be willing to work Eastern Time Zone and attend onsite business critical meetings as necessary. Reports directly to the Head, US Regulatory Advertising and Promotion Policy (RAPP). Member of RAPP Leadership Team. Are you looking for a highly visible regulatory advertising and promotion policy leadership role where you can accelerate regulatory compliance on an international scale? If so, this Senior Director, Team Lead, Regulatory Advertising and Promotion Policy is an great opportunity to consider. This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following: Responsibilities and Accountabilities Lead a regulatory advertising and promotion team for assigned therapeutic area(s) to provide strategic regulatory advice that competitively positions assigned products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Partner with commercial and other stakeholders to develop strategy and product positioning that aligns commercial strategy with regulations. Drive optimal regulatory strategy, planning and delivery for advertising and promotion to support the overall business goals for therapeutic area(s) of focus. Maintain an expert understanding of FDA regulations, guidance, and evolving regulatory environment and apply this insight to support innovative practices in advertising and promotion. Serve as a liaison with OPDP and/or APLB reviewers for business-critical initiatives. Provide regulatory consultative support and influence on above-brand, cross-functional teams. Provide regulatory risk assessment and disposition for escalated topics within assigned therapeutic area(s) (beyond the level of the copy approval team or promotional review committee). Provide creative solutions and strategies, including risk mitigation strategies. Conduct regulatory assessment and provide interpretation of new and updated FDA guidance in the area of advertising and promotion. Provide support in the establishment of a regulatory position for GSK. In collaboration with commercial, medical, and legal colleagues, evaluate the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling, while preempting areas of potential concern related to proposed promotional materials. Provide consistent, well-supported, and clear guidance to key stakeholders. Act as regulatory advertising and promotion lead on cross-functional matrix teams supporting early pipeline assets and pre-launch products for future promotional impact. Provide strategic advice on early asset, launch, and lifecycle product activities (e.g., clinical trial protocols, substantiation for claims, labeling review). Develop and deliver departmental objectives through active engagement with regulatory management as a member of the RAPP Leadership Team. Coach and lead team members through regulatory risk assessments, issue identification, business interactions, and key stakeholder engagement, counseling on complex and novel concepts. Provide team members with honest and timely constructive feedback and performance assessments. Provide guidance and coaching to improve performance and support / promote individual development plans. Grow an inclusive and diverse team based on empowerment, trust and open communication Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Undergraduate degree in biological or healthcare science. Advanced degree preferred. Extensive experience in pharmaceutical/biologics regulatory, or scientific discipline. Extensive experience in interpretation and application of FDA regulations and guidance relating to prescription drug advertising and promotion. Experience in direct management of staff with a track record of success including providing direction, building teams, driving alignment to business goals and staff development. Demonstrated ability to be provide regulatory strategies that influence commercial success in a compliant manner. Expert knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences. History of successful interactions with OPDP reviewers for multiple products, across a range of therapeutic areas. Experience providing regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials. Experience providing leadership related to issues of critical importance (e.g., providing regulatory advice involving regulatory issues on topics for which there may not be clear/specific regulatory insights). Strong understanding of the drug development process, including clinical trial design and labeling development process. Experience leading and influencing in multidisciplinary matrix team environment. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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