- Sumitomo Pharma (Boston, MA)
- …Programming Organization. + Create/acquire tools to improve programming efficiency or quality . + Establish monitoring of data transfers for ongoing trials to ... + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc....to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- Beth Israel Lahey Health (Boston, MA)
- …plan, prioritize and implement operational goals, as well as establish appropriate quality control procedures to ensure compliance with federal, state, local, and ... forums. 5. Collaborates with CCTO Director to develop and implement appropriate quality control guidelines to ensure all study conduct activities conform to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement ... are addressed. + Communicate internal and external resource and quality issues that may impact deliverables or timelines of...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Norstella (Boston, MA)
- …intelligence content development, driving process automation, and implementing cross-functional quality and publishing enhancements. The role combines deep industry ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more
- Fujifilm (Boston, MA)
- …as required, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all ... in the investigation of product complaints dispositioned within the Quality Review Board (QRB) process. + Creates and ensures...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Bristol Myers Squibb (Devens, MA)
- …data flow and strong information security. + Ensure strict adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation, ... objectives. The Senior Manager collaborates cross-functionally with laboratory, manufacturing, quality , automation, and global IT teams to deliver solutions that… more
- Fujifilm (Boston, MA)
- …systems. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Sanofi Group (Cambridge, MA)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues and fraud and abuse) as well as proposed solutions to… more
- Fujifilm (Boston, MA)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... with our MI Marketing Operations team, product owners, sales leadership, finance, quality assurance, legal and order management. The CPQ Product Marketing Manager… more
- Fujifilm (Boston, MA)
- …consistently high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that ... with MI Project Management (PM) team to deliver high quality Synapse product solutions. + Act as primary technical...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more