Associate Director Global Regulatory Affairs jobs at Incyte in United States, Wilmington
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Company (1)
Job type
Job categories
Job title (1)
United States
State
Wilmington
18 jobs found
03.09.2025
I
Incyte Associate Director Biostatistics United States, Delaware, Wilmington
Participate in the development and enforcement of SOPs and guidelines. Participate in regulatory activities such as health authority meetings and submission related activities. Participate and contribute to authoring of Clinical...
Design and author protocols for clinical studies. Responsible for providing clinical input into eCRF design, SAP, and TLFs. Collaborate with study team members to conduct timely and thorough review of...
Lead device development activities with confidence and experience to deliver on commitments, including timeline management, budget management, scope, contracts and other device / molecule and business needs. Drive the technical...
Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards. Author new and/or revised CCDS, USPI and...
Collaborate with Executive Director IAI and Global Product Team to refine clinical development and commercialization strategies. Evaluate and advance innovative formulations, combination products, and delivery mechanisms for dermatology. Guide late-stage...
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...
Participate in the development and enforcement of SOPs and guidelines. Participate in regulatory activities such as health authority meetings and submission related activities. Participate and contribute to authoring of Clinical...
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