- Baystate Health (Springfield, MA)
- …in matters of corporate law, business transactions, financing, medical staff, regulatory compliance, health law, legal aspects of drug diversion detection, ... of Trustees and physicians on state, federal and other regulatory agency guidelines in matters relating to corporate business...by state/federal agencies such as Attorney General's office, federal FDA or DEA, HCFA, State Board of Registration in… more
- Pfizer (Cambridge, MA)
- …analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. + Provides statistical input to study designs and can ... design and data analysis strategies to meet project objectives with high quality in a timely manner. * Provide statistical inputs on clinical development… more
- Philips (Cambridge, MA)
- …within the Clinical and Medical functions, as well as cross-functionally with Regulatory , R&D, Quality , HEMAR, Biostatistics and Data Management, Clinical ... dissemination of evidence derived from clinical development endeavors, engaging with regulatory bodies and influential stakeholders to shape policy and industry… more
- Sanofi Group (Cambridge, MA)
- …candidate will work collaboratively in matrixed, cross-functional teams to generate high- quality and comprehensive data packages to nominate and advance therapeutic ... across internal groups and with external partners. + Prepare high- quality analyses, interpretation, documentation, and presentations to support project milestones,… more
- Charles River Laboratories (Wilmington, MA)
- …timely and ethical delivery of NHPs. * Stay current on industry trends, regulatory changes, and competitor activity to inform strategy and maintain a competitive ... pharmaceutical and CRO landscape, particularly in preclinical development. * Knowledge of regulatory and ethical considerations related to the use of NHPs in… more
- Hologic (Marlborough, MA)
- …from concept through commercial launch. You will collaborate across engineering, regulatory , manufacturing, and quality teams-making high-level design decisions, ... solutions under development meet intended purpose and comply with regulatory and quality standards. + Serve as...medical imaging technologies. + Thorough understanding of medical devices, FDA QSR, ISO 13485, and relevant risk and electrical… more
- Oracle (Boston, MA)
- …role plays a critical part in ensuring the reliability, security, and regulatory compliance of medical devices, mobile devices, printers, and other equipment ... essential to delivering high- quality patient care. You'll work closely with technical teams, support staff, healthcare partners, and vendors to ensure the reliable… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- 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