Labelling Strategy and Development, Oncology Team Lead

Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia Posted Date: Dec 1 2021 Director, Labelling Strategy and Development Oncology Team Lead will have responsibility for the initiation and development of labelling in alignment with the Target Medicines Profile (TMP) and Target Vaccines Profile (TVP) for Oncology assets from phase 1 through to early life. The teams will be comprised of staff in UK, Europe (aligned with RDCs) and US. The portfolio will require direction and excellent cross team collaboration for the development and authoring of global product information (Global PI) for Oncology products and provide advice to GSK teams on GLC requirements/ processes and on EU/ US regulatory requirements. Leads will interact with senior stakeholders including in: R&D, Regulatory, Safety, and Commercial. They will be accountable for providing innovative approaches/recommendations to product labeling that meet corporate goals while maintaining compliance with relevant laws and regulations. Accountable for management of the One Development labelling process and labelling development for a the Oncology portfolio. Provide appropriate labelling resource to the regulatory matrix teams aligned with portfolio priorities. Ensure close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic and proactive labelling development. Interfaces directly with GSK senior management, functional experts, on business strategy and labelling content. Works closely with the aligned Therapeutic/Vx RDC VP and with US AdPromo team to drive all labelling aspects for the defined portfolio. Directs labelling development, critically evaluating the data and principles upon which labelling statements are based so as to ensure clinical relevance and regulatory acceptance across the designated portfolio. Commercially astute, with strong understanding of competitor labels and evolving external labelling trends and agency requirements Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously, and employs sound judgment in solving complex problems and issues. Internally, influences key proposed guidelines and regulations to shape external environment. Work with Commercial colleagues to understand competitive landscape and desired endpoints in labelling. May be active in external facing activities and is effective at representing GSK in various industry groups (such as DIA) or at EMA- or FDA-sponsored events (e.g., Workshops, AdComs). Line manage, recruit, and motivate staff within the Labelling Development team. Contribute to the leadership of the Development Labelling Organization and drive effective governance through the GLC processes. Significant labelling and project team experience. Drug development, regulatory requirements, labelling experience, line and/or matrix leadership. Highly developed interpersonal, presentation and communication skills with established internal and external networks. The ability to influence effectively in a matrix. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Science, Medicine or Pharmacy, or work experience equivalent. Extensive Regulatory experience including in depth Labelling knowledge and experience with line and matrix leadership experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree, PharmD, or PhD in Science, Medicine or Pharmacy; or work experience equivalent. *LI-GSK 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. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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