- The Building People (Leesburg, VA)
- …including but not limited to compliance, risk management, negotiation and quality control. As one of America's fastest growing and nationally recognized ... small businesses, the Contracts Manager will be the primary lead to ensure our organization is delivering with the...overseeing all contractual actions while setting the standard for quality delivery. Critical path items include the need to… more
- ExecuNet (Reston, VA)
- …management capabilities. Regulatory and Governance Accountabilities: * Lead regulatory and compliance programs related to data and analytics assets. -- ... timely, available, secure and consistent. -- Develop and maintain controls on data quality , interoperability and sources to effectively manage corporate risk… more
- The Aerospace Corporation (Chantilly, VA)
- …Coordinates and advises Contracts and Property personnel on property regulatory issues and requirements interpretation. Demonstrates behavior that is consistent ... the preparation of audit review packages by gathering the required information. Analyzes data and data collection strategies to maximize efficiency and ensure… more
- Frederick National Laboratory for Cancer Research (Frederick, MD)
- …in a related field. Qualifying experience of four (4) years in quality assurance, regulatory science, biology, chemistry, biochemistry, or pharmaceutical ... /compilation of technical CMC content sections, including narrative text / data tables and relevant reports, for Module 3 (+...job related experience including two (2) years as a lead or supervisor Experience in regulatory submission… more
- Freddie Mac (Mclean, VA)
- …on the role of Business Continuity Management. Participate in BCP Testing Exercises. Lead the annual review of BCPs and informing business owners of updates and ... mitigation of business interruption and other risks caused by business, regulatory , or industry-specific change initiatives. Monitor and track program compliance and… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …each of us to achieve our goal to develop and deliver medicines.The 'R&D Quality Assurance Audit team' provides excellence in audit across the R&D operations at ... based in Gaithersburg, USA you will be the Team Lead for the group of auditors delivering the R&D...delivering the R&D QA Audit Program for GCP, GVP, Data Integrity and external vendors. You will work alongside… more
- Unknown (Fort Detrick, MD)
- … Data Architect / Analyst's position will create actionable, high-impact plans that improve data integration, data quality and data delivery in ... data structures that are efficient, scalable, uphold data integrity and quality , easily maintained.Support customer...data in the architecture.Stay abreast of existing emerging regulatory developments and requirements for data and… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- At AstraZeneca, we lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of ... seek strong talent to join our teams.Advances in digitalization, data and advance analytics are changing industries at pace...(goal -20% reduction in cost per patient per year) quality at source, patient experience and probability of successStage… more
- BrainScope(R) (Bethesda, MD)
- …and incoming data to support data handling processes ensuring data integrity is maintained by performing regular quality checks, query management and ... and results, along with managing a high volume of data with multiple modalities. This position: Reports to Chief...in all work decisions to uphold BrainScope's "Culture of Quality " We offer a competitive salary, strong benefits and… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …be based in our Cambridge, UK offices, or in Gaithersburg, US. Typical Accountabilities Lead Oncology Data Science and Data Strategy planning and ... or coordinates a diverse range of initiatives to improve quality , integrity of information interpretation, cost or time and...globallyAbility to serve as "translator" between scientific problems to data science solutions and to lead others… more
- Novavax (Gaithersburg, MD)
- …interpreting clinical and/or experimental data . Will ensure that corporate, quality , regulatory and safety procedures/requirements are being observed and ... quadrivalent influenza nanoparticle vaccine (NanoFlu), to address key factors that can lead to the poor effectiveness of currently approved flu vaccines.ResVax, an… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …groups.Accountability for ensuring compliance for all AZ and site specific policies, quality standards, SOPs, regulatory requirements, SHE and Human and Animal ... an Associate Director Imaging & AI - Imaging & Data Analytics who will manage a group of tissue...vivo imaging technologies. This position offers the opportunity to lead all aspects of how we investigate both the… more
- NTT DATA Services (Rockville, MD)
- …people who work here. NTT DATA Services currently seeks a Senior System Security Lead to join our team in Rockville , Maryland (US-MD) , United States (US) . ... Req ID: 84171 At NTT DATA Services, we know that with the right...the right people on board, anything is possible. The quality , integrity, and commitment of our employees are key… more
- Unknown (Gaithersburg, MD)
- …(PBRER) - Investigators brochures (IB) - Data submission strategy, ie, legacy data , pooling data , communications with regulatory agencies - Etc. ... Science or Life Science Comprehensive knowledge of technical and regulatory requirements related to the role Knowledge of CDSIC...project in one or more of the following areas: Lead the provision of technical consulting expertise to external… more
- Pharmaron (Germantown, MD)
- …regulations. Identify critical non-compliances and report them immediately to the Study Lead , Director of Quality Assurance, and Test Site Management. Provide ... quality issues. Schedule and execute audits of plans, data , and reports for accuracy and compliance for regulated... Assurance Metrics Report to Management. Provide support for Regulatory and client inspections. Quality Assurance Unit… more
- Dynex Technologies, Inc. (Chantilly, VA)
- Job Title: Director, Assay Applications Laboratory Job Summary: Lead an Assay Applications Team that will be responsible for evaluating, demonstrating feasibility ... with internal development team and external partners to establish Multiplier feasibility data . Support technology transfer to partners. Support transfer of assays to… more
- Emergent BioSolutions, Inc. (Gaithersburg, MD)
- …and time lines. As a critical member of Clinical Development Product Teams: Lead or contribute to, as appropriate, the development of, review and approve clinical ... documents. Oversight of CROs and other vendors as necessary. Collaborate with Regulatory Affairs for the preparation and execution of study related documents,… more
- Novavax (Gaithersburg, MD)
- …Writing Services will be responsible for managing the life cycle of high- quality and submission-ready clinical, regulatory , statistical, and scientific documents ... nanoparticle vaccine (NanoFlu), to address key factors that can lead to the poor effectiveness of currently approved flu...of documents used with external facing audiences (medical, legal, regulatory review and approvals) - MRL Data … more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …R&D organisation. We drive excellent design in order to generate the appropriate data needed for quality decision making. The goal of Oncology Biometrics ... submissions, programming and information deliverables, commercialization and scientific utilization data for AstraZeneca's oncology products. You will lead the… more
- Novavax (Gaithersburg, MD)
- …quadrivalent influenza nanoparticle vaccine (NanoFlu), to address key factors that can lead to the poor effectiveness of currently approved flu vaccines.ResVax, an ... program(s) in compliance with Good Clinical Practices (GCP) and global regulatory requirements, to include:Oversight of pharmacovigilance activities for an assigned… more
