- Leica Biosystems (Miami, FL)
- …PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners to develop ... about the Danaher Business System which makes everything possible.The Senior Principal , Regulatory Affairs is responsible for regulatory strategy… more
- Cleerly (Denver, CO)
- …and will be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory ... of submission documents. Excellent organizational, writing and verbal communication skills. Principal Regulatory Affairs Specialist (Specific) Experience:… more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for planning/managing real world ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionThe Director ( Principal Scientist) has primary responsibility for the planning...Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting,… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …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 primary responsibility for the planning and directing clinical research activities involving new or… more
- Inside Higher Ed (Columbus, GA)
- …highly motivated peers.Responsibilities Executive Leadership and Strategy:- Serve as a principal advisor and thought partner to the President, supporting high-level ... with demonstrated experience in executive leadership, project management, or campus affairs . Proven ability to manage complex projects, build consensus, and… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …in the BrCa space Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... collaborators to develop translational analysis plans and timelines, communicate analysis results Represents the Solid Tumor Translational Development function at various internal meetings and provide domain knowledge and disease expertise to cross-functional… more
- Syneos Health Careers (Morrisville, NC)
- Description Principal Biostatistician (LP Oncology - US Remote) Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to ... accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …and applicable internal resources such as manufacturing and specialty labs. Engage central Regulatory Affairs Specialists when an IND submission is required and ... are actively expanding our Clinical Research Support (CRS) team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …success in clinical research field is preferred. Must have strong knowledge of regulatory affairs , research ethics and the responsible conduct of research. ... startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking… more
- Sony Corporation (Culver City, CA)
- …with Government Affairs group in connection with tax legislative and regulatory initiatives Coordinating with tax compliance team to ensure the proper reporting ... US headquarters of Sony Group Corporation, based in Tokyo, Japan. Sony's principal US businesses include Sony Electronics Inc., Sony Interactive Entertainment LLC,… more
- Children's National Hospital (Silver Spring, MD)
- …the Office of Innovation Technology Development, the Clinical Trials Office and Regulatory Affairs to meet institutional goals and metrics. Obtain necessary ... agreements and financial terms/budgets not only meet the needs of the Principal Investigators, but also protect the interests of the organization, are legal… more
- Shaw University (Raleigh, NC)
- …basis only. *Follows and ensures compliance with external regulatory institutions and organizations. *Follows established financial guidelines, including ... *Participates in programs of community service organizations. *Participates in public affairs through work with the local, state, or national governments. 11.… more
- MannKind Corporation (Thousand Oaks, CA)
- …Partner closely with various departments, such as field sales management, regulatory affairs , R&D, Legal/Compliance, Strategic Partnerships and Advocacy and ... tactics required to maximize the value of our products. Principal Responsibilities: Brand Management: Build and maintain a strong...medical affairs . Strong collaboration, align efforts, gather input, and drive… more
- Topography Health (San Diego, CA)
- …clinical trials. Work effectively with cross-functional teams, including clinical operations, regulatory affairs , and data management. Participate in team ... five years of experience in clinical trials, with specific experience as Principal Investigator of vaccine or infectious disease studies. You should have prior… more
