Project Manager Global Launch Projects - Partner Markets jobs at Incyte in United States, Wilmington
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Job title (1)
United States
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Wilmington
8 jobs found
25.05.2025
I
Incyte Associate Director Global Regulatory Affairs United States, Delaware, Wilmington
Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents...
Governance and Maintenance of all Templates and Clause Library configured into CLM. Govern and maintain contract templates. Collaborate with Legal Counsel and other relevant functional area stakeholders, as it relates...
Deliver therapeutic information on products in line with marketing strategy. Promote INCYTE IAI Dermatology product to prescribing Dermatologist specialists in compliance within compliance and legal requirements and according to the...
Deliver therapeutic information on products in line with marketing strategy. Promote INCYTE IAI Dermatology product to prescribing Dermatologist specialists in compliance within compliance and legal requirements and according to the...
Support activities required within process chemistry, pharmaceutical and analytical development to ensure submission readiness of drugs into international markets. Manage the GMP/GDP readiness of new products for international markets. Provide...
Development of protocols for clinical studies. Preparation of clinical development plans. Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions. Monitor,...
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...
Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents...
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