- Bayer (Cambridge, MA)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Senior Director , Global Regulatory Leader-IVD** The Senior Director , ... TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director , Global Regulatory Leader-IVD are to:...effectively deal with issues such as product safety and drug / device regulation and compliance with internal and… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE** **AND** **SCOPE:** The Senior Director , Sales Training & Development is responsible for leading the strategy, design, and execution of sales training ... development, along with experience navigating complex healthcare markets. The Senior Director will apply an enterprise mindset,...including at least 5 years in pharmaceutical or medical device sales training and education, and 5+ years in… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned oncology pharmaceutical / biological / drug - device combined products, accountable for the safety strategy and ... to the Takeda Safety Board and similar forums. The Senior Medical Director will be a key...support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …work with portfolio teams to optimize top-tier development cycle times to accelerate drug to patients. **Accountabilities:** + Senior level R&D CMC portfolio ... for facilitating the Pharm Sci CMC Governance advisory board, comprised of senior -level CMC experts to advise Pharm Sci teams towards winning CMC development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges that arise ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...(MS), with Ph.D. preferred. + 15+ years of seasoned biopharmaceutical/ device industry experience or with a regulatory agency, while… more
- Sanofi Group (Cambridge, MA)
- …products, departmental activities, and direct reports. + In conjunction with the Sr . Director /Product Support Head, imparts senior regulatory guidance ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the development, ... maintenance, and implementation of Instruction for Use (IFU) documents and Device Container Labeling content in line with US and EU standards and guidelines. Provide… more
- Takeda Pharmaceuticals (Boston, MA)
- …and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development and ... + Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions. + Understands and interprets… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug - device combined products, accountable for the safety strategy and major ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… more
- Fujifilm (Boston, MA)
- …other duties as assigned. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... Biomarkers sales through that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a...all capital equipment i30 placements as directed by the Director of Sales and Marketing. + The territory is… more