- Dana-Farber Cancer Institute (Brookline, MA)
- …the Senior Director , Quality Assurance and Regulatory Compliance , the Director , Clinical Regulatory Compliance is responsible for the program ... program to ensure adherence to all accreditation, licensing, and clinical regulatory standards. The Director ...+ Strong knowledge of quality measurements, health care policy, clinical regulatory compliance , and patient… more
- United Therapeutics (Boston, MA)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Counsel, Regulatory & Compliance role is responsible for a broad range of ... approval for five medicines, we are always conducting new clinical trials, and we are working to create an...legal, regulatory and compliance issues affecting the pharmaceutical… more
- Sumitomo Pharma (Boston, MA)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide strategic review… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory , Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you... submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle… more
- Bristol Myers Squibb (Devens, MA)
- …QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance + Demonstrated strong ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is...to promote a culture of quality, risk management and compliance excellence. The Senior Director will also… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …network, and (c) strategies for regional/domestic clinical growth, and (d) clinical joint ventures. The Associate Director will be responsible for the ... closely with clinical and administrative leaders and staff. The Associate Director and their team will conduct analyses and provide expertise to inform internal… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of Nursing. This leader is accountable for APRN practice standards, regulatory compliance , credentialing, and professional advancement. He/she is accountable ... The Dana Farber Cancer Institute (DFCI) the Director of Advanced Practice Nursing provides clinical...just culture in the care environment. + Assures APRN compliance with regulatory requirements, ie licensure, credentialing,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Research Director **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed ... be critical in helping our teams accelerate progress. The Clinical Research Director (CRD) is noted as...contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good … more
- Merck (Boston, MA)
- … clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may ... and the further study of marketed compounds. **In executing these duties, the Senior Director may:** + Supervise the activities of Clinical Scientists in the… more
- Takeda Pharmaceuticals (Boston, MA)
- …in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships. + ... years of experience in the pharmaceutical industry, with 6+ years in Regulatory Affairs, quality assurance/ compliance , or research and development. + Extensive… more
- Sanofi Group (Cambridge, MA)
- …Head, Research Scientist, Clinical Pharmacologist, Biomarker Lead, Safety Medical Director , Statistician, Regulatory and other key functional leads. The role ... you thought was possible. Ready to get started? This Clinical Research Director (CRD) role in Early...the clinical development plan, designing and executing clinical trials, analyzing trial data, interacting with regulatory… more
- Novo Nordisk (Lexington, MA)
- …clinical experts, and Principal Investigators. Relationships Reports to: Senior Medical Director , GNAT Early Clinical Development. Work with the Early ... US Clinical Development Group, whose functions include Drug Safety, Regulatory Affairs, Clinical Operations, Medical Writing, Biostatistics, Data Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Quantitative Clinical Pharmacology Lead in Cambridge, MA, where you ... (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in...external partners. + Maintains a high standard for good clinical practice, compliance , and ethics. + Mentors… more
- Monte Nido (Waltham, MA)
- …while providing the opportunity for people to realize their healthy selves. ** Clinical Director ** **WaldenBehavioral Care** **Waltham, MA** **Monte Nido & ... within an intimate home setting. We are seeking a Clinical Director to work at Walden Behavioral...insurance payers. + Previous experience with Joint Commission and regulatory standards compliance is desired. + Ability… more
- Sanofi Group (Cambridge, MA)
- …the limits of what you thought was possible. Ready to get started? The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is ... with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery,… more
- Sanofi Group (Waltham, MA)
- **Job title: Director Non- clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the ** Director of Non- clinical Biostatistics** where you will lead a team of… more
- Takeda Pharmaceuticals (Boston, MA)
- …company to inspire you and empower you to shine? Join us as the Director , Global Clinical Supply Chain Planning based in Cambridge or Lexington, MA ... new capabilities and improve existing processes/systems **_A_** **_CCOUNTABILITIES:_** + The Director (Team Lead), Global Clinical Supply Chain Planning will… more
- Bristol Myers Squibb (Cambridge, MA)
- …oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for ... board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects +… more
- Sanofi Group (Cambridge, MA)
- … trials, drafts protocols and informed consent documents, and addresses queries from regulatory bodies, IRBs, and ethics committees. Reviews clinical data and ... and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents.… more
- ThermoFisher Scientific (Waltham, MA)
- …suppliers + Requires knowledge of onboarding due diligence and continuous assessment of regulatory , compliance , and risk for suppliers used for global ... 1B-4) across all therapeutic areas. Categories include diagnostic services, Clinical IT Solutions, Decentralized trial services, Centralized services, patient… more