- National Institutes of Health (Montgomery County, MD)
- …Employment Qualifications Education Qualification Requirement: In order to qualify for a Lead Regulatory Operations Specialist-GS-0601-14, position you must ... Requirement: In addition, in order to qualify for a Lead Regulatory Operations Specialist, GS-0601-14,...applications; providing guidance on regulations, policies, and procedures governing clinical trials operations and regulatory … more
- Merck (Washington, DC)
- …high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical ... GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully… more
- Humana (Washington, DC)
- …and help us put health first** Humana Healthy Horizons is seeking a Capture Lead , Clinical & Population Health Strategy, to lead initiatives developing ... experts to synthesize, assess, and translate state requirements into actionable go-to-market clinical strategy. The Lead will consult with growth partners to… more
- Merck (Washington, DC)
- …+ Works in partnership internally with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs, pharmacovigilance, legal ... + Required to in/directly influence investigators, external partners and country operations to successfully delivers clinical and financial contracts within… more
- Takeda Pharmaceuticals (Washington, DC)
- …team members ( Clinical , Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations , Drug Discovery Units, DMPK&M, and ... management, with ability to prioritize, manage multiple programs within strict regulatory /compliance deadlines, and lead internal/external and scientific teams… more
- Amgen (Washington, DC)
- …priorities needs and timelines are met + Serve as the primary interface with Clinical Development, Quality, and Regulatory Affairs to ensure coordination of all ... a regulated environment, preferable pharmaceutical, GMP environment, and knowledge of regulatory guidelines impacting clinical supplies (ie GxP, GDP guidelines,… more
- General Dynamics Information Technology (Bethesda, MD)
- …of related experience **Job Description:** GDIT's Military Health Team is hiring a Sr. Clinical Research Director to lead a research team for the Traumatic Brain ... for this position. **SUMMARY:** S/he provides leadership to ensure all operations support clinical research investigations and, where applicable, patient… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. ** Clinical Systems & Analytical Reporting, Senior Manager** **What you will do** Let's do ... technologies. The successful candidate will have a strong technical background in clinical trial applications (eg, eTMF, CTMS, EDC, site facing technologies) and be… more
- Amgen (Washington, DC)
- …related field, including 4 years of biopharmaceutical clinical product development ( clinical research or clinical operations experience obtained at a ... Join us and transform the lives of patients while transforming your career. ** Clinical Systems & Analytical Reporting Manager** **What you will do** Let's do this.… more
- Trinity Health (Silver Spring, MD)
- …is responsible and accountable for leading and managing assigned departmental operations and associated functions. This position ensures that the department operates ... that meets organizational goals and objectives while maintaining compliance with regulatory and accreditation standards, as well as hospital policies and… more
- Takeda Pharmaceuticals (Washington, DC)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... Global Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead and Labeling Compliance to ensure… more
- Trinity Health (Silver Spring, MD)
- … Lead Case Manager for the Care Management Department serves as the lead clinical resource for case managers, working collaboratively with department managers ... collaboration. + Provide expertise in areas related to quality improvement, clinical documentation enhancement, reimbursement, and regulatory matters. + Maintain… more
- Trinity Health (Germantown, MD)
- …and federal regulations. Ability to provide or coordinate in-service training to clinical /professional staff on medical device operations and safety functions. ... **Employment Type:** Full time **Shift:** **Description:** **POSITION PURPOSE** Assists Clinical Engineering Manager in planning, developing, and implementing the… more
- Cardinal Health (Washington, DC)
- …staff. This is an individual contributor role that reports to the Sr. Director of Clinical Operations . Candidates can live anywhere in the United States but must ... the continuum of care. The team's mission is to provide exceptional clinical , supply chain, analytics, and operational expertise to improve patient access, increase… more
- Merck (Washington, DC)
- …cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for ophthalmologic disorders. You will ... Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within and… more
- HCA Healthcare (Dulles, VA)
- …leadership to effectively grow the Behavioral Health Services by ensuring clinical excellence, operating efficiency and financial strength. This includes leadership ... and partnership with Medical Director and medical staff to ensure the clinical excellence and operational performance of the Behavioral Health Services. The… more
- IQVIA (Washington, DC)
- …of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the ... the Therapeutic Strategy VP will be expected to: + Lead and support clinical trial design and...clients. + Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory… more
- ThermoFisher Scientific (Washington, DC)
- …that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services provide ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Charles River Laboratories (Rockville, MD)
- …and actions are taken, documented, and completed to ensure compliance to regulatory and industry quality standards. The Site Quality Head is also responsible ... **Essential Duties and Responsibilities** * Primary Quality contact for all regulatory interactions with all domestic and world regulatory authorities,… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Accountabilities** *Develop, lead , and serve as the primary point of contact for the statistical program ... and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product *Partner with CfDA Design & Innovation to drive… more