Senior Manager, Labelling Strategy and Development

Job Purpose:

Accountable to drive and deliver US Product Information (PI) (including healthcare professional and patient information) 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.

This is a hybrid role based at our Upper Providence site in Collegeville, PA requiring 2-3 days on-site per week average.

Key Responsibilities:

The role is accountable for authoring and maintaining USPI for a portfolio of Established Products (EP), in conjunction with functional experts, and for authoring US patient information. The incumbent may also generate responses to FDA questions related to US prescriber and patient information.

The role may include some global labelling 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 (e.g., Global Labelling Operations and Regulatory Therapeutic Group) 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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

• 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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/