- 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
- Dana-Farber Cancer Institute (Brookline, MA)
- …domestic affiliate network, (c) strategies for regional/domestic clinical growth (d) clinical joint ventures. The Associate Director will be responsible for ... 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
- 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
- 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
- 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
- Merck (Boston, MA)
- **Job Description** The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all ... authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance , Regulatory , Pharmacovigilance (PV) and Medical Affairs. + Responsible… 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
- 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
- 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
- Brockton Hospital (Brockton, MA)
- …resources to make a difference in the lives and health of our patients. The Assistant Director , Corporate Compliance (Assistant Director ) is a member of the ... for assisting the Chief Compliance Officer (CCO) with the institutional compliance program planning and execution. The Assistant Director will utilize prior… more
- WelbeHealth (Boston, MA)
- … Compliance Operations has a deep understanding of PACE and clinical compliance regulations, and experience implementing and maintaining programs. **Essential ... to provide all-inclusive care to our most vulnerable senior population. The Director , Compliance Operations is accountable for developing, coordinating and… more
- Takeda Pharmaceuticals (Boston, MA)
- …improvement + Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Dana-Farber Cancer Institute (Boston, MA)
- … clinical research and program development across the department. The Associate Director ensures compliance with all regulatory policies and guidelines ... in associated program activities, has direct supervisory responsibilities for the clinical research managers and regulatory coordinators and indirect ongoing… more