Regulatory Affairs Management

Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 23 2022 Are you an enthusiastic regulatory professional with experience or an interest in developing patient and prescriber information while pursuing a career in a global pharmaceutical company?    If so, GSK currently has opportunities in its Global Regulatory Affairs (GRA)- Labelling Strategy and Development department and this Labelling Manager role may be an ideal opportunity for you to explore.  At GSK, we're constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer.  Ensuring these products are correctly prescribed and used is essential, and that's where our Strategic Labelling team is key.  The Strategic Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Company Core Datasheet, which contains information for prescribers and patients.  As a Labelling Manager in the US based team, you will help us support our exciting pipeline of new products.  This includes primarily work on the Company Core Datasheet as well as the US PI prescriber and patient information. Because it is a global role, we also provide labelling support to colleagues in markets worldwide. Our labelling development team supports a product during development and throughout its early lifecycle, and we are the authors of Company Core Datasheets for GSK pharmaceutical products.  You will liaise with colleagues in clinical, safety and other regulatory functions to ensure that the Prescribing Information, Patient Leaflets and Packaging Components accurately state the Company's medical and scientific position regarding the safe and effective use of a GSK product, active ingredient or device.  This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following: Lead the development of the Company Core Datasheet for new medicines or product line extensions. Development of prescribing and patient information for US market. Work with colleagues in markets worldwide to ensure implementation of the company core datasheet into local prescribing/patient information. Author responses to regulatory questions on prescribing/patient information from Regulatory Authorities. Author documentation to support Labelling Committee. Interface with key labelling and governance stakeholders across GSK. Manage documentation to support global and country/regional product information (PI) development and early maintenance. Author and manage US PI for products registered in the US. Management of GRA Labelling data in appropriate systems and databases (primarily Veeva vault). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Life sciences/pharmacy degree (or PhD). Preferred Qualifications: If you have the following characteristics, it would be a plus: PharmD or higher degree Demonstrated high attention to detail and accuracy. Specific experience with prescribing/patient information.   Track record of authoring clear scientific labelling text for health professionals and patients Experience in managing senior stakeholders to meet internal and external deadlines Ability to recognize and resolve conflicts Ability to work in complex matrix teams Excellent communication skills Relevant Labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic area experience.  Demonstrates an understanding of company priorities and responds appropriately with flexibility to ensure deadlines are met successfully. Shows a focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Ability to make sound decisions. Proactively seek information, guidance and insight from a broad range of sources and weigh benefits and risks before making important decisions. Proven leadership skills 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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