Job Responsibilities :
Responsible for the production (authoring or assisting the authors), in terms of quality and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US.
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Identifies and resolves problems in a proactive manner.-
Suggests creative approaches to capture labeling concepts in a succinct manner.-
Ensures appropriate consistency in labeling documents across products for assigned area of responsibility.-
Works with Labeling Strategy staff to ensure compliance with US Labeling processes.-
Must be able to effectively articulate FDA and GSK requirements for labeling documents to GSK matrix teams, champion change, and recommend unique solutions, as needed.-
Ensures all labeling regulatory requirements associated with assigned products are met.-
Works with Matrix Team to resolve any labeling issues in a proactive manner.-
Ensures accurate version control of multiple labeling submissions and components.-
Develops FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines.-
Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.-
Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.-
Completes all assigned tasks to project deadlines.-
Is able to manage own time at the task level and works on multiple projects in parallel.-
Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports.-
The major outputs of this position are Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and GSK Matrix Teams.-
Ensuring prescribing information for prescription products in the US meet all regulatory requirements.
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Ensuring proper version control of US prescribing information.-
This role does not require the management of staff. Some training or mentoring of staff may be required.
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Why You?
Basic Qualifications
Understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines.
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Proficient with computer software applications.-
Familiarity with medical terminology.
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Preferred Qualifications
Undergraduate Degree in a Science or Life Science area or equivalent practical experience.
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Labeling and Regulatory experience in the pharmaceutical industry.-
Knowledge of FDA regulations relevant to labeling.-
Knowledge of XML labeling-
Ability to negotiate solutions to labeling issues.-
Ability to work on multiple projects with attention to detail.-
Excellent written and oral communication skills.-
Ability to work with project teams to resolve issues regarding prescribing information requirements.-
Effectively builds positive relationships within Labeling team and with other GSK colleagues.-
Ability to identify issues and independently devise and implement solutions.-
Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully.
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#LI-GSK
Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance
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.
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