- Georgetown Univerisity (Washington, DC)
- …inquiry and making a difference in the world. Requirements Regulatory Associate - Clinical Research Management Office - Georgetown University ... The Regulatory Associate is responsible for conducting regulatory activities for clinical trials in the Clinical Research Management Office… more
- Kelly Services (Washington, DC)
- …take the next step in your career, trust The Experts at Hiring Experts. The Sr. Clinical Research Associate is responsible for in the execution of ... protocol, monitoring plan, case report forms, etc.). + Remain current on clinical trial regulatory requirements and guidelines (eg GCP, ICH, FDA, etc) with the… more
- GAP Solutions Inc (Bethesda, MD)
- … Research Coordinator (CCRC). + Certified Clinical Research Associate (CCRA). + Experience liaising with regulatory authorities. + Experience with ... The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit… more
- Georgetown Univerisity (Washington, DC)
- …interested in intellectual inquiry and making a difference in the world. Requirements Clinical Research Coordinator 2 - Department of Neurology - Georgetown ... University Medical Center The Clinical Research Coordinator 2 (CRC2) manages and...On a daily basis, the CRC2 reports to the Associate Director of Clinical Trials, and is… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …(GCP) and Human Subjects Protection (HSP) DESIRED SKILLS AND EXPERIENCE: + Certified Clinical Research Associate (CCRA) + DoD experience REQUIRED CITIZENSHIP ... REQUIRED SKILLS AND EXPERIENCE: + Knowledge and experience in the areas of clinical research and regulatory affairs as related to clinical studies,… more
- Amgen (Washington, DC)
- …research and scientific experience Or + Bachelor's degree and 8 years of related research and scientific experience Or + Associate 's degree and 10 years of ... time for a career you can be proud of. ** Regulatory Real World Evidence (RWE), Manager** **Live** **What you...for observational studies and for studies combining RWD and clinical trial data + Provide support to therapeutic area… more
- Merck (Rockville, MD)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine + Develops worldwide product...to facilitate initial approval by agencies for conduct of clinical trials + Participate in regulatory due… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …Positions to Include: + + Laboratory Research Associate + Animal Behavior Research Assistant + Clinical Research Coordinator I & II REQUIRED SKILLS ... and update all applicable regulatory files and documentation for all regulatory guidelines for human and animal research , including appropriate institutional… more
- Amgen (Washington, DC)
- …across the drug development and commercialization lifecycle. The data we produce informs clinical trial design, supports regulatory decision making and aids in ... for a career you can be proud of. **Observational Research Senior Manager** **Live** **What you will do** Are...and effectiveness of an Amgen medicine to inform a regulatory decision (eg, label expansion/change) and fulfill a global… more
- Amgen (Washington, DC)
- …world. In this vital role you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). The Senior Manager, ... clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals). You will play a vital role...and quality by design are a core responsibility. Or Associate 's degree and 10 years of **Quality Management** ,… more
- Amgen (Washington, DC)
- …of clinical research experience OR Bachelor's degree and 7 years of clinical research experience OR Associate 's degree and 12 years of clinical ... medical monitoring and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects +… more
- Merck (Washington, DC)
- … expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), ... clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings. **Minimum education required:** + Ph.D. with 1-3 years of pharmaceutical… more
- Amgen (Washington, DC)
- …and instructs others in statistical areas relating to randomized and non-randomized clinical research + Strong analytical and problem-solving skills + Proficient ... for a career you can be proud of. Biostatistics Associate Director **Live** **What you will do** Let's do...Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and… more
- Amgen (Rockville, MD)
- …perform SAS programming validation if needed + Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy ... or medical research _._ + Life Cycle Drug Development Experience (Pre- clinical Development, Clinical Development, and Post-marketing) + Strong verbal and… more
- Amgen (Washington, DC)
- … Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents. + Oversees statistical work performed ... Demonstrated ability to provide sound strategic and statistical input on study or research design to meet project needs and regulatory and scientific… more
- Amgen (Washington, DC)
- …Digital Medicine, Clinical Systems and Applications, Representation in Clinical Research ). + Lead supplier evaluation, qualification, & remediation ... in life sciences or medically related field, including 3 years' experience biopharmaceutical clinical research experience ( clinical research experience… more
- Amgen (Washington, DC)
- …in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience ( clinical research experience obtained ... experience **Or** + Bachelor's degree and 6 years of Clinical experience **Or** + Associate 's degree and...CRO company) + Experience working with and/or oversight of clinical research suppliers (eg CROs, central labs,… more
- CareFirst (Washington, DC)
- …a value-based health care system. Responsible for the thorough research , development, maintenance, and implementation of evidence-based, clinically sound, ... relations with providers and the community. We are looking for an experienced clinical leader in the greater Baltimore metropolitan area who is willing and able… more
- Amgen (Washington, DC)
- …will lead the development of tools/resources to communicate the disease burden, clinical efficacy and safety, and healthcare economic messaging to best position ... RWE) **Key Activities:** + Develop key value resources that incorporate clinical , pharmacoeconomic, and real-world evidence for use with payers, including formulary… more
- Amgen (Washington, DC)
- …will lead the development of tools/resources to communicate the disease burden, clinical efficacy and safety, and healthcare economic messaging to best position ... of HEOR/CfOR RWE) + Develop key value resources that incorporate DSE, clinical , pharmacoeconomic, and real-world evidence for use with payers, including formulary… more