- Merck & Co. (Boston, MA)
- Job DescriptionThe Senior Director ( Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Merck & Co. (Boston, MA)
- …our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies ... Diagnostics, Next Generation Sequencing (NGS), Professional Networking, Project Management, Regulatory Affairs Compliance {+ 3 more}-Preferred Skills:Job Posting… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Medtronic (Boston, MA)
- …barriers to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key ... regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility for... regulatory requirements and partners with the international regulatory affairs group to support regulatory… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... and drive the timely delivery of high-quality pharmaceutical products. ** PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy...of experience in regulatory affairs , focusing on regulatory … more
- Merck (Boston, MA)
- **Job Description** The Director/ Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...and external to GRACS. **Key functions:** + Reports to Senior Principal Scientist ( Senior Director)… more
- Merck (Boston, MA)
- **Job Description** The Senior Director ( Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities ... + Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development… more
- Bristol Myers Squibb (Cambridge, MA)
- …the PC space + Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies in… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- HNTB (Boston, MA)
- …protocols to ensure compliance with design criteria, scientific specifications, and regulatory approvals/permits. + Serves as senior reviewer of technical ... of proposed projects. + Serves as task lead or principal author in the preparation of reports, on environmental...state, and federal environmental permits as well as other regulatory compliance laws and regulations. + Organizes and participates… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and … more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... is true to the best of my knowledge. **Job Description** **Objective:** ** Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the… more
- HNTB (Chelmsford, MA)
- …ensure compliance with design criteria, scientific specifications, contract specifications, and regulatory approvals/permits. + Serves as senior reviewer of ... reports on findings and coordinates with the project staff and environmental regulatory agencies to resolve identified corrective actions. May serve as the interface… more
