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the acquisition and divestiture of TMF contentwhile developing repeatable efficient process for TMF in integrations Lead design and execution of remediation projects and improvement projects Configure Study
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, approaches of different reimbursement bodies) and lead the data generation process in countries in alignment with these. Excellent verbal and written communication skills including scientific writing skills
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programs and HTA analysis, approaches of different reimbursement bodies) and lead the data generation process in countries in alignment with these. Excellent verbal and written communication skills including
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ROLE SUMMARY: Lead as a player/coach the group of Asset Quality Leaders and accountable for the management and oversight of GCP performance and quality systems within the oncology portfolio
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assets or CD&O process area and drive learnings across their tumor type(s). Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities. Oversee program and study-level
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strategic regulatory expertise as Global regulatory representative to Product Team(s). As a Director, Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory
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practices for partnered programs. You will ensure creation of strategic and operational objectives from early (lead) development through Proof of Concept and licensure of the product depending on the program
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ROLE SUMMARY: Lead as a player/coach the group of Asset Quality Leaders and accountable for the management and oversight of GCP performance and quality systems within the oncology portfolio
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regulations Independently conducts wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed) Executes audit strategy, leads/supports process audits, and may
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affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and