- Takeda Pharmaceuticals (Boston, MA)
- …global initiatives **Accountabilities:** **Program Leadership** **:** + Provides strategic scientific leadership and program management for multiple global CMC ... development teams dealing with complex development programs that require scientific depth and overall product development acumen for successful execution +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …lead to drive a MIDD path within each project. + Leads strategic, scientific , and operational aspects of multiple drug development projects with a high level ... and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and… more
- Sanofi Group (Cambridge, MA)
- …close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology, and to incorporate new methodologies ... and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + Advance the… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …ensure alignment of technical activities with regulatory strategies. + Utilizes scientific training when interfacing with Management of technical areas and project ... around emerging/changing regulatory requirements. + Writes documents with complex scientific information for regulatory submissions. + May supervise staff +… more
- Merck (Boston, MA)
- …field-based employees such as the Vaccine Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director (RMD) as well as other members ... and health care environment knowledge through self-study of company-provided scientific , product and marketplace information, attendance at product workshops and… more
- Sanofi Group (Cambridge, MA)
- …a positive, collaborative mindset. + Take an active part in the scientific challenges involved in early clinical development, which require a scientifically ... (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs , Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development… more
- Merck (Boston, MA)
- …Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide final ... Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead ... through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic… more
- Takeda Pharmaceuticals (Lexington, MA)
- …USBU and Global level on relevant internal meetings, understanding the US scientific and medical landscape and patient/medical journey for assigned pipeline assets ... program, or where appropriate, other Global-driven initiatives. + Serve as medical and scientific in-house expert for assigned TA and asset, working with various US… more
- Takeda Pharmaceuticals (Lexington, MA)
- …execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated ... US Medical Clinical Research, and in collaboration with US MA Medical and Scientific Leads. + Leads the project risk management process and generates the… more
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