Senior Manager/associate Director International jobs at Incyte in United States, Wilmington
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Company (1)
Job type
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Job title (1)
United States
State
Wilmington
30 jobs found
05.01.2025
I
Incyte Senior Manager/Associate Director International United States, Delaware, Wilmington
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.,...
Job Summary (Primary function)Job Summary (Primary function)The Senior Administrative Assistant handles a wide range of administrative and executive support related tasks.Essential Functions of the Job (Key responsibilities)Responsible for heavy calendar...
Develop strategy to deliver an acceptable and product specific analytical package to support clinical studies from Phase 1 to BLA. Write, review and approve analytical and stability sections for regulatory...
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...
Conduct process analysis, simplification and intensification for APIs and their intermediates. Plan how to move laboratory synthetic procedures into a pilot production phase, then onto large-scale industrial processing. Develop methods...
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...
Contribute to the development of clinical development strategy for development assets. Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs...
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.,...
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