Senior Manager, Labelling Strategy and Development
Women In Bio, Collegeville, Pennsylvania, United States, 19426
Job Purpose
Accountable to drive and deliver US Product Information (PI) for Established Products (EP) in compliance with internal and external standards, processes and policies. Interface directly with all GSK functional experts who contribute data for US Prescribing Information and ensure compliance with GSK Regulatory Submission processes. The role may include some global labelling responsibilities.
Key Responsibilities
Authors healthcare professional and patient information for assigned products for the US market and ensures compliance with US Local Labelling processes including submission of Country Labelling Differences.
Develops high quality USPI and associated strategy for EP products by providing local regulatory advice and expertise regarding US prescribing and patient information requirements, precedents, and competitor labelling.
Authors responses to labelling questions from the FDA.
Ensures effective communication within Labelling Strategy and Governance, and with other GSK labelling groups regarding issues which may impact other GSK products.
Makes well thought out, efficient decisions, with some guidance from Line Manager, based on pertinent facts, relevant information, risk assessment and good judgment with respect to the compliance of healthcare professional and patient information with reference to GSK internal standards, and US regulatory requirements.
Works flexibly but within the limitations of internal and external requirements to facilitate risk mitigation within project teams, such as anticipating regulators' questions regarding data, format, or content.
Demonstrates knowledge of relevant US regulations and guidances, and adapts to changes in regulatory requirements and internal standards as required.
In conjunction with the GRA Regional Director, represents GSK at label meetings with FDA.
Basic Qualifications
Bachelor's Degree in Life Sciences related discipline
8 plus years' experience in pharmaceutical regulatory affairs
4 plus years in a labelling-focused role in a matrixed environment
Experience authoring or contributing to core US labelling documents (e.g. USPI, patient information)
Experience with cross-functional labeling reviews involving Regulatory, Medical Affairs, Safety/Pharmacovigilance, Legal, CMC and Commercial teams
Preferred Qualifications
MS, PharmD, PhD
Developed interpersonal, presentation and communication skills
Influences effectively in a matrix environment
Recognizes key issues which require escalation
Runs efficient meetings
Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully
Why GSK Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr
Key Responsibilities
Authors healthcare professional and patient information for assigned products for the US market and ensures compliance with US Local Labelling processes including submission of Country Labelling Differences.
Develops high quality USPI and associated strategy for EP products by providing local regulatory advice and expertise regarding US prescribing and patient information requirements, precedents, and competitor labelling.
Authors responses to labelling questions from the FDA.
Ensures effective communication within Labelling Strategy and Governance, and with other GSK labelling groups regarding issues which may impact other GSK products.
Makes well thought out, efficient decisions, with some guidance from Line Manager, based on pertinent facts, relevant information, risk assessment and good judgment with respect to the compliance of healthcare professional and patient information with reference to GSK internal standards, and US regulatory requirements.
Works flexibly but within the limitations of internal and external requirements to facilitate risk mitigation within project teams, such as anticipating regulators' questions regarding data, format, or content.
Demonstrates knowledge of relevant US regulations and guidances, and adapts to changes in regulatory requirements and internal standards as required.
In conjunction with the GRA Regional Director, represents GSK at label meetings with FDA.
Basic Qualifications
Bachelor's Degree in Life Sciences related discipline
8 plus years' experience in pharmaceutical regulatory affairs
4 plus years in a labelling-focused role in a matrixed environment
Experience authoring or contributing to core US labelling documents (e.g. USPI, patient information)
Experience with cross-functional labeling reviews involving Regulatory, Medical Affairs, Safety/Pharmacovigilance, Legal, CMC and Commercial teams
Preferred Qualifications
MS, PharmD, PhD
Developed interpersonal, presentation and communication skills
Influences effectively in a matrix environment
Recognizes key issues which require escalation
Runs efficient meetings
Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully
Why GSK Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr