Labeling Program Specialist #4070 id-7813

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Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
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This individual will be responsible for establishing, implementing, maintaining, and improving GRAIL’s product labeling program and acts as technical lead supporting technical operation on process monitoring, troubleshooting and investigation. This person works closely with Regulatory, Quality, Supply Chain, R&D and Clinical Laboratory. The person in this role consistently applies critical thinking skills and good judgment to solve broad, complex problems, effectively establishing and cascading functional strategy and decisions across teams and communicating status and recommendations to executive management.
Key responsibilities include providing expertise and strategic oversight to 1) ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagn

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ostic Regulation (IVDR), ISO 13485, ISO 14971, ISO 15189,  21 CFR 820, 21 CFR 809, and related medical device regulations and 2) ensure technical operation is effectively, and timely identifying and containing Clinical Lab production issues by supporting process monitoring, troubleshooting and investigation.

Responsibilities:

    • Ownership of efficient, effective, and compliant processes and their governing procedures for GRAIL’s product labeling.
    • Assigns label part numbers to all device labeling.
    • Establishes and maintains labeling specifications (printed and electronic).
    • Establishes and maintains source artwork files adhering to labeling specifications.
    • Ensures all label claims are substantiated through the Design History File in partnership with Regulatory and Design teams.
    • Initiates and drives to completion Veeva change control workflows for labeling specifications, source artwork, and final labels initiation and change management.
    • Represents the Labeling Program as Subject Matter Expert during audits and inspections
    • Maintains and continually improves the Labeling Program to ensure state of the art labeling controls at GRAIL.
    • Where applicable, acts as technical lead on process monitoring, troubleshooting and deeper investigations

Preferred Qualifications:

    • Bachelor’s degree in a science, engineering, or other technical area.
    • 12+ years of experience with medical device or pharmaceutical product labeling operations or NGS assays.
    • Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 809, 21 CFR 820, ISO 13485, ISO 14971, ISO 15189, MDR/IVDR.
    • Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
    • Excellent written and verbal communication skills and attention to detail.
    • Ability to comprehend and interpret technical information related to GRAIL’s product claims.
Desired Qualifications and experience
    • Master’s degree in a related technical area, or MBA.
    • Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.

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