- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more
- Eversource Energy (Westwood, MA)
- …cross\-functional teams including System Planning, Engineering, Siting, Real Estate, Legal, Engagement, Regulatory Affairs , and more + Ensures that all strategic ... Strategic Projects + Assists with representing Eversource Transmission at public meetings, regulatory hearings, town hall meetings and any special meetings that may… more
- Fresenius Medical Center (Waltham, MA)
- …reports on audit findings and corrective and preventive action recommendations to Regulatory Affairs , Quality as well as operations management and corporate ... **PURPOSE AND SCOPE:** Leads regulatory surveys and promotes utilization of continuous quality improvement (CQI) principles, methods, and tools. Directs,… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support… more
- Astrix Technology (Boston, MA)
- …Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that ... decisions. + Compliance and Reporting: Ensure all activities comply with regulatory standards and company policies, and accurately document interactions and insights… more
- Astrix Technology (Boston, MA)
- …+ Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and execute clinical strategy. + ... including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input in alignment… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution + Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... Massachusetts DPH, the Boards of Registration in Medicine and Nursing, and other regulatory agencies as needed. In particular lead the investigation and response to… more
- AbbVie (Worcester, MA)
- …guidelines. + Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with project ... guidelines, ensuring methods are suitable for late-phase development and regulatory submissions. + Experience using automation to standardize high-throughput… more
- Sanofi Group (Cambridge, MA)
- …SKU portfolio rationalization program in collaboration with Franchises, TA Lead, Regulatory Affairs , Finance & Com ops **About You** ... **Skills/Expertise/Experience:** + Experience in developing strategies and budgeting long-range planning + Solid knowledge of IBP process + Experience with performance and capability in enabling and driving change + Strong communication and influencing skills,… more
- Amgen (Cambridge, MA)
- …closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs , to ensure alignment and successful design transfer. ... deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + **Design Transfer Execution:** Develop and… more