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The Vice President, Head Global Regulatory Strategy is responsible for providing strategic and operational leadership for all planning, management, support and execution of global regulatory activities across all products in development and in commerce. The incumbent is also responsible for ensuring that regulatory strategies are executed in compliance with current, appli
Posted 12 days ago
The Research Fellow, Chemical Process Development coordinates activities in Active Pharmaceutical Ingredients (API) process scale up, process improvement and process optimization studies. The incumbent supports the transfer of technology to commercial manufacturing partners, monitors the manufacture of API and monitors stability data generated by Contract Manufacturing Or
Posted 18 days ago
The Vice President, Global Medial Affairs is the head of the Global central medical functions responsible for aligning key scientific objectives of the global medical organization with the broader strategic and cross functional objectives including partnering with commercial, clinical development, regulatory, patient advocacy and other corporate support functions. This pe
Posted 23 days ago
The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating procedures and processes and biostatistics compu
Posted 24 days ago
The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials. This includes, but is not limited to identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, interpreting the resulting findings and c
Posted 25 days ago
The Associate Director, Regulatory Affairs CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements. This position works cross functionally with Regulatory Af
Posted 30 days ago
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