Manager Global Distribution Quality jobs at Incyte in United States, Wilmington
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Company (1)
Job type
Job categories
Job title (1)
United States
State
Wilmington
12 jobs found
21.01.2025
I
Incyte Senior Manager / Associate Director Clinical Research Scient... United States, Delaware, Wilmington
Lead Safety Management Team and direct all safety risk management activities for assigned products. Ensure local and global risk management plan preparation and execution throughout a medicinal product’s lifecycle. Formulate...
Lead the creation, review, and submission of regulatory documents, ensuring compliance with global regulatory standards across the international region, ensuring a collaborative and inclusive environment. Review regulatory submission materials (e.g.,...
Establishes and maintains a strong relationship with Contract Packaging Organizations (CPO) in order to execute all planned activities in a timely manner. Prepares and recommends operating plans with CPO counterparts...
Conducting internal and external audits to ensure all GLP/cGLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to. Perform Preclinical QA qualification and routine audits for all...
Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities. Ensures documents and RIM objects comply with submission ready standards and guidelines...
Template Governance and Maintenance of all Templates and Clause Library (Global remit)Establish, govern and maintain globalized, refined, well defined, easy to use Legal contracting templatesEstablish, socialize, gain alignment and document...
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