- 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
- Novo Nordisk (Washington, DC)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- System One (Bethesda, MD)
- …Bethesda, MD area (candidates in DC and Northern, VA will also be considered) Title: Clinical Research Associate Start Date - 07/06/2024 End Date - ... Knowledge, Skills and Abilities: + Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. + Good… more
- Guidehouse (Bethesda, MD)
- … Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA) + Liaising with regulatory authorities + Training clinical trial ... 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
- 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)
- …experience Or Bachelor's degree and 8 years of data sciences and/or scientific/observational research experience Or Associate 's degree and 10 years of data ... for a career you can be proud of. **Observational Research Senior Manager** **Live** **What you will do** Let's...papers + Participate in submission planning and discussions with regulatory agencies + Set annual product-specific and personal goals… 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
- 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
- Merck (Washington, DC)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This Associate … more
- Veterans Affairs, Veterans Health Administration (Washington, DC)
- …Prevention. Responsibilities Major duties include but are not limited to: The Associate Director Education supports the Deputy Director and the Senior Consultant for ... guidance for suicide prevention for the Department of Veterans Affairs. The Associate Director Education provides support to the operationalization of the VA's… more
- Charles River Laboratories (Rockville, MD)
- …a career that you can feel passionate about. **Job Summary** The Biomanufacturing Associate I will play an integral role within CRL's gene therapy manufacturing ... Testing Solutions** With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for… more
- Charles River Laboratories (Rockville, MD)
- …candidate to join our growing business in the CMO industry. The QC Associate II will perform microbiological testing, static and dynamic viable and non-viable ... Testing Solutions** With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for… more
- Zimmer Biomet (Washington, DC)
- …relationships with key functional areas - Research , Business Development, Finance, Clinical , Commercial, Legal and Regulatory . + Analyze the data related to ... respected, empowered, and recognized. **What You Can Expect** The Program Associate Director will oversee lifecycle management business processes to enable the… 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