Site Name: USA - Pennsylvania - Upper Providence, USA - North Carolina - Research Triangle Park Posted Date: Oct 25 2021 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 department, within research and development, 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 labelling team is key. The 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, including therapy for Covid-19. These are global roles and you will be providing labelling support to colleagues in markets worldwide. This may include work on the US PI; European SPC, patient information leaflet and label; and prescribing/patient information for other major international markets, including Asia Pacific and key emerging markets. 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 EU and US markets. Manage core and local prescribing/patient information through development and for newly approved products. 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. Author and manage EU PI annexes for products registered via the EU centralised procedure. 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 Two or more years regulatory experience Preferred Qualifications: If you have the following characteristics, it would be a plus: PharmD or related role. Clinical experience is desired (Pharmacist, RN, etc.) Vaccines experience highly desired. Demonstrated high attention to detail and accuracy. Experience in managing senior stakeholders to meet internal and external deadlines Ability to recognize and resolve conflicts Ability to work in complex matrix teams Track record of authoring clear scientific labelling text for health professionals and patients Excellent communication skills Specific experience with prescribing/patient information. 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. 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. 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