• Kyowa Kirin, Inc. (Honolulu, HI)
    …and local medical conferences.Actively participate in advisory boards and clinical investigator meetings.Provide quality and appropriate feedback to headquarters ... needs with available Kyowa Kirin resources.Support clinical research activities ( investigator initiated and company sponsored).Facilitate speaker development and training.Engage… more
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  • ORIC Pharmaceuticals, Inc. (San Diego, CA)
    …and editorial skills, ability to collaborate on development of high- quality clinical-regulatory documents, eg, investigator brochures, meeting ... This involves working closely with cross-functional colleagues including regulatory operations, quality , CMC, nonclinical and clinical team members. S/he will be a… more
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  • Rhythm Pharmaceuticals, Inc (Boston, MA)
    …and our tenacity to overcome barriers, together.Opportunity OverviewThe Head, GCP Quality Assurance provides strategic leadership and direction for clinical ... quality assurance operations and other prioritized needs, ensuring Rhythm's...the clinical program team to provide compliance guidance across investigator sites, vendors, and internal processes. Lead regulatory inspections,… more
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  • Stirling Q&R Ltd (Boston, MA)
    …in the pharmaceutical industry is seeking a Director to lead their Clinical Quality Assurance (CQA) efforts with a strong focus on Good Clinical Practices (GCP) ... continuous improvement. Key Responsibilities: Develop and implement a comprehensive GCP quality assurance strategy that aligns with ICH E6(R2) guidelines and… more
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  • Dennis Partners (Boston, MA)
    …neurodegenerative diseases. They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as the primary contact ... and consultants, as well as other duties as appropriate.Build the company's quality system; formulate the company's GMP, GLP and GCP compliance strategies and… more
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  • Gilead Sciences, Inc. (Foster City, CA)
    …4 studies in HIV prevention, and help to oversee Gilead's HIV prevention investigator sponsored research (ISR) program. The ideal candidate will be an established ... product launches for future long-acting HIV prevention assets.Oversee Gilead's investigator sponsored research program in HIV prevention, including determining ISR… more
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  • THE GENEVA FOUNDATION (Bethesda, MD)
    About the Position The Executive Director, 4DBio3 serves to advance high- quality research and education by promoting an environment that fosters collaboration and ... Collaborate with Geneva corporate and program leadership and Principal Investigator (s) on audits, administration, and regulatory compliance activities Maintain data… more
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  • Syneos Health/ inVentiv Health Commercial LLC (Washington, DC)
    …strategies, suggest local outreach options, facilitate escalation of investigator questions/concerns, recruitment/retention initiatives and clinical site & ... client; suggest and support implementation of local outreach options.Communicates investigator /study coordinator inquiries requiring follow-up to designated contacts and… more
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  • KARL STORZ SE & Co. KG (El Segundo, CA)
    …our products and services help to save lives around the globe. Therefore, we make quality and reliability our number one priority.Get to know us and join our team ... identify and mitigate risk.Establish product testing protocols to ensure product quality and safety.Strategize with MSA Leadership team and lead external educational… more
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  • University of California San Francisco (San Francisco, CA)
    …clinical trials, basic science research, and supportive care trials to improve the quality of life for persons living with dementia as well as prevention and ... Spanish, Cantonese, Mandarin, Tagalog) and multicultural team dedicated to improving the quality of health care for vulnerable communities in San Francisco and… more
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  • University of California - San Francisco Campus and Health (San Francisco, CA)
    …clinical trials, basic science research, and supportive care trials to improve the quality of life for persons living with dementia as well as prevention and ... Spanish, Cantonese, Mandarin, Tagalog) and multicultural team dedicated to improving the quality of health care for vulnerable communities in San Francisco and… more
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  • Enrs Go (Washington, DC)
    …The PhD in Nursing Program Director is responsible for the leadership, operations, and quality of the PhD in Nursing Program at GUSON. The program is primarily a ... for PhD in Nursing Program . Lead, plan, and coordinate program operations, quality , and growth Coordinate, direct and implement the PhD curriculum and programmatic… more
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  • Parkview Health (Fort Wayne, IN)
    …Connections to industry for trials and opportunities for cooperative and investigator -initiated research are available and encouraged. We have had approximately 8% ... the opportunity to be highly selective and seek physicians focused on high- quality subspecialized patient care, looking to establish their long-term career, and who… more
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  • Regeneron Pharmaceuticals, Inc (Basking Ridge, NJ)
    …team and external functional service providers, to ensure timely and high- quality results. Own the development, dissemination, and implementation of programming ... programming team to evaluate and develop solutions for project resourcing, quality , timelines, and budget.Keeps senior leadership advised of decisions and issues… more
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  • Regeneron Pharmaceuticals, Inc (Sleepy Hollow, NY)
    …and dissemination of clinical and non-clinical data and results in high quality publications.Acting as standing or ad-hoc member for various teams; providing ... Affairs clinical trials. Ensuring timely submission and delivery of high- quality clinical trial documentation, implementation and execution.Continuing to develop and… more
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  • CLevelCrossing (San Francisco, CA)
    …or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions. Grow and mentor ... with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions required.… more
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  • University of California - San Francisco Campus and Health (San Francisco, CA)
    …mission of the Memory and Aging Center (MAC) is to provide the highest quality of care for individuals with cognitive problems, to conduct research on causes and ... behavioral, neuroanatomic) characteristics of various neurodegenerative diseases. The Primary Investigator 's (PI) research within the MAC focuses on the… more
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  • Tufts University (Washington, DC)
    …leverage resources across departments and partners to serve student and investigator needs. Prepare communications materials and present findings and accomplishments ... of three professional references Tufts University, founded in 1852, prioritizes quality teaching, highly competitive basic and applied research, and a commitment… more
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  • Genmab A/S (Princeton, NJ)
    investigator -initiated trials program, within appropriate standards for compliance, quality , timeliness, and budget.Contribute and execute on the life cycle ... management of the asset(s).Drive collaboration with cross-functional teams (eg, commercial, field/regional, medical information/communication, HEOR) to provide support, medical review, and medical expertise advice as required.Collaborate with medical and… more
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  • Takeda Pharmaceuticals (Washington, DC)
    …facilitation of strategically aligned medical collaborative studies and investigator -initiated research processes.Display advanced knowledge of therapeutic area key ... through poster/session attendance and KOL/HCP interactions).Within defined timelines and quality standards, respond to unsolicited HCP medical information inquiries… more
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