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J&J Family of Companies
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North Brabant,
Netherlands
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Manager Regulatory Medical Writing, Oncology - 2406179316W
Description
Manager Regulatory Medical Writing, Oncology
At Johnson & Johnson Innovative Medicine, what matters most is
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J&J Family of Companies
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South Holland,
Netherlands
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Manager, Regulatory Program Manager (RPM) - Oncology (1 of 2) - 2406191837W
Description
Johnson and Johnson is recruiting for a Regulatory Program Manager, Oncology. This position can be located
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J&J Family of Companies
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South Holland,
Netherlands
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opportunities for the IPV Leadership team
Collaborate on regulatory compliance for MD portfolio with ... processes
Demonstrable insight into the development of regulatory requirements with knowledge of Global
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J&J Family of Companies
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South Holland,
Netherlands
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working conditions, ensuring compliance with Standard Operating Procedures (SOPs) and relevant regulatory ... , scientific advancements, and regulatory requirements, and share knowledge with the team.
**Qualifications
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J&J Family of Companies
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South Holland,
Netherlands
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of processes and equipment, reflecting a commitment to excellence and regulatory compliance. Support
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J&J Family of Companies
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Netherlands
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clinical trials, investigator meetings, regulatory interactions, and study and submission document writing ... Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
Authorship of abstracts and
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J&J Family of Companies
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South Holland,
Netherlands
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policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory ... ensuring continuous compliance with relevant regulatory health authority requirements, effective risk
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J&J Family of Companies
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South Holland,
Netherlands
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with study / site feasibility, study/project management, monitoring, clinical and regulatory operations ... , representatives from Commercial, Procurement, IT, Legal, Regulatory and HCC
External: Investigational sites
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J&J Family of Companies
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South Holland,
Netherlands
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pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content
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J&J Family of Companies
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North Brabant,
Netherlands
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with Standard Operating Procedures (SOPs), Health Care Compliance (HCC) and local regulatory
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J&J Family of Companies
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South Holland,
Netherlands
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applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire ... compliant state with its procedures, work instructions and all applicable regulatory GxP requirements
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J&J Family of Companies
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South Holland,
Netherlands
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regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life ... all applicable regulatory GxP requirements throughout the entire system life cycle.
Ensure
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J&J Family of Companies
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Utrecht,
Netherlands
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obligations, in pharmacovigilance, regulatory, quality and medical information
Qualifications
**What
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J&J Family of Companies
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South Holland,
Netherlands
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Maintains front-line knowledge of Good Manufacturing Practices (GMP) and regulatory issues (e.g., audit
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J&J Family of Companies
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Netherlands
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regulatory requirements are incorporated.
Coordinate/lead key design reviews with SMEs including other
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