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Job Description Summary

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process.

Job Description

In this role, you will lead and oversee GE HealthCare Pharmaceutical Diagnostics’ global labelling strategy, operations, and compliance, including creation and maintenance of labelling documents; and in doing so bring about enterprise-level change to better meet the needs of a growing business. You will be responsible for implementing and managing processes around labelling globally, overseeing labelling activities worldwide for marketed products, creating and maintaining Company Core Data sheets, and also providing strategic advice in the creation of target labelling for development products. Reporting to the Executive Head of Quality and Regulatory Affairs, you will also be a key member of the QRA and RA Leadership teams.

Key responsibilities

• Directly oversee and provide strategic and tactical advice for the maintenance and development of CCDS and local labelling deliverables for regulatory filings

• Chair cross-functional Global Labelling Committee and Labelling Working Groups to manage the decision-making process for labelling updates to established products

• Design and implement strategy for the creation of a dedicated Global Labelling function

• Develop, improve, implement and document best-in-class labelling processes, metrics and templates, including influencing stakeholders at all levels

• Lead development of labelling for products in all stages of development including creation of Target Product Labels

• Liaise with other Regulatory Affairs functions to ensure labelling updates are submitted and implemented

• Monitor consistency between local labelling documents and Company Core Data Sheets, and ensure exceptions are documented through standard process

• Provide strategic interpretations of labelling regulations and guidelines in a range of markets including US and EU

• Ensure compliance and performance of labelling processes in accordance with departmental KPIs

• Input into requirements for tools and systems required for the compliant management of labelling documents

Qualification requirements

• Minimum of a Bachelor’s Degree, preferably in a Scientific or Life Sciences Discipline

• Significant Regulatory Affairs Labelling experience, including direct experience with CCDS, Core Product Information and local labelling in a range of markets including US and EU

• Experience leading labelling professionals and preferably a global labelling team.

• Experience with label development including TPP

• Experience developing, implementing and operating global labelling processes for a pharmaceutical company with worldwide product licences

Desired Characteristics::

• Strong interpersonal skills, ability to forge connections and to influence stakeholders at all levels, in all regions

• Ability to clearly explain labelling concepts to senior stakeholders and Regulatory Affairs colleagues globally

• Ability to identify problems and their solutions, as well as driving them to resolution, delegating where necessary to achieve results

• Ability to learn new technologies, tools and systems quickly – experience with Veeva RIM Submissions and Registrations Vault desired

• Project management experience

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No

Application Deadline: szeptember 02, 2024