Jobs in All Categories (5) Healthcare (1) Human Resources & Legal (1) Operations & General Management (2) Science & Education (1)
Conducting audits and providing Quality oversight for key vendors such as CROs, Investigator Sites, and Specialty Pharmacies, REMS Coordinating Centers and Pharmacovigilance providers
Lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Aegerion SOPs.
Manage planning, preparation and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings)
Leading cross-functional teams to ensure all stakeholders are aware of program activity; to frame important strategic and tactical issues and contingencies; and to ensure timely decision-making
Develop and execute detailed packaging and labeling plans for relevant countries and clinical studies considering current and future material availability and country specific shelf life requirements