• MacroGenics (Rockville, MD)
    …Brochures, IND/NDA. Supports all clinical writing activities outlined in the Project Clinical Development Plans with minimal direction and guidance. ... of the organization. Summary of Position Responsible for supporting Clinical Development in clinical protocol... clinical protocols, protocol amendments, Investigator's Brochure, and clinical study reports Sr . Medical Writer *… more
    MacroGenics (12/19/17)
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  • Altarum Institute (Rockville, MD)
    clinical trials that includes, but not limited to study design, budget development and management, clinical research project management with multi-site ... Overview KAI Research is currently seeking a Sr . Clinical Research Scientist (CRS) to...Medical and Clinical Research Directors, and other Clinical Development colleagues in the delivery of… more
    Altarum Institute (12/23/17)
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  • Quintiles Inc. (Rockville, MD)
    …studies in partnership with sales and other functions. * Driving solutions around the clinical development plan, project and protocol. * Partner with ... worldwide. We're looking for an established oncology physician with strong clinical development experience to join us as a Medical Strategy Leader. This… more
    Quintiles Inc. (12/05/17)
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  • MacroGenics (Rockville, MD)
    Overview MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of ... to learn and grow as a means to further their professional development . MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and… more
    MacroGenics (01/12/18)
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  • Emergent BioSolutions (Gaithersburg, MD)
    … study with the guidance of a Clinical Project Manager (CPM) or Senior CPM ( Sr . CPM), to ensure compliance with Good Clinical Practices, SOPs and ... professional skills to develop products designed-to protect life. The Senior Clinical Project Specialist provides...lead for a program at the discretion of the Clinical Project Manager (CPM, or Sr more
    Emergent BioSolutions (12/05/17)
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  • AstraZeneca (Gaithersburg, MD)
    …in Clinical Data Management to provide oversight and advice to the clinical project team regarding the CDM activities and deliverables. Manages and resolves ... with Medimmune strategies and standards across therapeutic areas. Develops clinical project standards and processes based on...in the contract process for any CDM related activity ( Sr . DMPL only). People Management and development more
    AstraZeneca (12/05/17)
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  • AstraZeneca (Gaithersburg, MD)
    …mentor and manage a team of Clinical Operations Program Leaders and Clinical Project Managers dedicated to supporting the CVMD portfolio * Manage ... Level depending on level of experience. The Director / Sr . Director, CVMD Clinical Operations will be...rapidly changing trial portfolio * Ongoing capacity planning to project future resource needs and work with senior more
    AstraZeneca (12/19/17)
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  • Altarum Institute (Rockville, MD)
    …studies in a wide variety of therapeutic areas. We are seeking to hire a Senior Project Manager to manage projects. This position will be responsible for ... in a health-related field preferred. * 3-4 years of project management in a clinical research setting....FDA regulations as they pertain to the management of clinical studies. Knowledge of the software development more
    Altarum Institute (12/23/17)
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  • Altarum Institute (Rockville, MD)
    …health-research projects for government or commercial organizations. With limited supervision from senior staff, acts as project team leader for research ... in coordination of regulatory submissions as required Management and Development of Team/Staff * Assembles a project ...health-related field preferred * Two to four years of project management experience with clinical trials or… more
    Altarum Institute (01/04/18)
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  • AstraZeneca (Gaithersburg, MD)
    …to the design and interpretation of clinical studies and clinical development programs under the guidance of more senior staff. They provide direction ... health, and help fight and cure disease. As a Principal/ Sr . Principal Statistician, Oncology in Gaithersburg, MD, you'll play...project teams in the design and interpretation of clinical studies and clinical development more
    AstraZeneca (12/05/17)
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  • AstraZeneca (Gaithersburg, MD)
    …(2+ years) At least 4+ years total of pharmaceutical or relevant medical/ clinical experience minimum. * Understanding of drug development and commercialization ... As a Global Medical Affairs Leader (Grade F) / Senior Global Medical Affairs Leader (Grade G) - Immuno-Oncology...in Immuno-Oncology (IO), and deliver medical insight into the development and execution of an IO strategy. As the… more
    AstraZeneca (12/30/17)
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  • Emergent BioSolutions (Gaithersburg, MD)
    …he/she will provide regulatory strategy, direction, support and advice to the teams. The Sr . Manager will lead the development of a sound regulatory strategy and ... expeditious approval and maintain post-approval compliance * Provide regulatory intelligence for project teams and product development plans. * Work closely with… more
    Emergent BioSolutions (12/05/17)
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  • Emergent BioSolutions (Gaithersburg, MD)
    … studies with the guidance of a Clinical Project Manager (CPM) or Senior CPM ( Sr . CPM) to ensure compliance with Good Clinical Practices, SOPs and ... Clinical Research Organization (CRO) under guidance from the Clinical Project Manager (CPM or Senior...Development ). * Under supervision of the CPM (or Sr . CPM), provides support to clinical study… more
    Emergent BioSolutions (01/12/18)
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  • MacroGenics (Rockville, MD)
    …cooperation with other groups and departments including: Supply Chain, Analytical Development , Manufacturing, Regulatory, Quality, Clinical Development , etc. ... in advancing project and technical platforms relating to drug product development within the group. * Ensures manufacturing processes are sufficiently robust for… more
    MacroGenics (01/10/18)
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  • Leidos (Bethesda, MD)
    …comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development , and programmatic and project management support for ... Description: PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP)… more
    Leidos (12/05/17)
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  • REGENXBIO (Rockville, MD)
    …individual trials * Collaborate with Clinical Development or VP, Clinical Operations to drive best practices, ensuring project and functional objectives ... play a critical role that requires strong collaboration with clinical development and cross functions to complete....agreed budget, time and quality * Works closely with clinical project managers to develop risk and… more
    REGENXBIO (01/10/18)
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  • US Pharmacopeia (USP) (Rockville, MD)
    …products to meet customer and public health needs.Leads USP educational product development process by developing comprehensive project plans with internal ... in this role will be responsible for activities that facilitate the development , promotion and marketing of products for the USP Education and Implementation… more
    Careerbliss (01/14/18)
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  • Danone (Rockville, MD)
    Nutricia North America, a subsidiary of Danone, is looking for a Senior Brand Manager in the United States for Rockville, Maryland. Danone is a global food company ... autonomy and exciting career opportunities, Danone truly has something special inside. The Senior Brand Manager, Neocate Infant will lead the delivery of the Neocate… more
    Danone (01/14/18)
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  • AstraZeneca (Gaithersburg, MD)
    …and interact directly and independently with Biostatisticians, Data Management, Programmers, Clinical Development staff and management as a fully functioning ... will independently interact directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer.… more
    AstraZeneca (12/05/17)
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  • MacroGenics (Rockville, MD)
    …as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for ... for publications. Responsibilities and Job Duties: * Collaborates with colleagues in clinical development and operations, research, bioPharma development and… more
    MacroGenics (12/05/17)
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