- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs , ... (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... in all data management activities, databases and tracking systems.Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …critical operations related with Annual Product Reviews. Manages the completion of stability studies program of drug products marketed in US and exported from ... meet patient needs. Responsible to lead the activities related with stability studies program performance in accordance with internal procedures and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the internal and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical Monitoring activities are conducted in-house:-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the internal and external network. Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilities Medical Monitoring: For studies in which Medical Monitoring activities are conducted in-house:Provides… more
- Aequor (Providence, RI)
- …technical support) Previous experience with either synthetic or biologic stability program management (eg, designing studies , authoring stability study ... organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add… more
- Merck & Co. (North Wales, PA)
- …running multiple studies and protocolsKnowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the ... analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices ... (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study… more
- Insmed Incorporated (San Diego, CA)
- …the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies , review & interpretation of ... of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the clinical development team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop ... to design the audit framework globally for Research area, specifically GLP/GCLP studies .Partners with Audit and Compliance QA function to develop compliance and risk… more
- Eisai, Inc (Boston, MA)
- …planning.Research SupportFacilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary ... scientific expertise to Investigators involved in company sponsored post-marketing studies .Professional Organization SupportLead field medical efforts in support of… more
- Merck & Co. (Washington, DC)
- …leave-behinds, local, regional, and global company Footprints and access case studies , to support engagement on -cross-cutting policy issues.Develop and execute a ... to improve the Policy Academy, direct changes to and manage the program on day-to-day basis, including recruiting new associates, planning and executing professional… more
- Eisai, Inc (Nutley, NJ)
- …users are effectively utilizing the eTMF system for active and archived studies . This includes overseeing the daily global eTMF system related activities relating ... management concepts. Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines) Expertise within eTMF… more
- Novo Nordisk Inc. (Boulder, CO)
- …methods to CMOs/CROs and help with the direction of outsourced studies Physical Requirements 0-5% occasional overnight travel (domestic or international ... Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance;… more
- The George Washington University (Washington, DC)
- …and law student associations. Develop a new recruitment plan and work with Graduate and International Programs to initially create an LLM and MSL in Privacy and ... Technology Law. Then work with the Graduate and International Programs Office to recruit students for these new degreed programs . Assist the JD and Graduate… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and manages data collection and reporting for institutionally approved research studies . Ensures the requirements are met for subject enrollment and compliance ... study implementation process.Study Initiation: Plan, organize, implement clinical trials/research studies to effectively meet goals and ensure timely completion of… more
- MAHLE, Inc (Troy, MI)
- We move the world - together. As an international leading development partner and supplier to the automotive industry, we at MAHLE are passionate about developing ... your job at MAHLE. Get to know this leading international supplier to the automotive industry as an employer....of the project teams to ensure smooth launches of programs and launch readiness in SAP and EDICoordinate inbound… more
- Raytheon (Tucson, AZ)
- …the SI&T organization located in Tucson, AZ. The Senior SI&T Engineer is a key program role that is accountable for key decisions throughout the life cycle of the ... program which affects our competitive position and executability. Senior...a technical capacity. Prior experience with conducting UAS trade studies , UAS system development and design, UAS systems requirements… more
- Dexian - DISYS (Harrisburg, NC)
- …who is interested in this type career.4 year degree in securities studies could be a fitPotential titles: travel risk specialist, security analyst (avoid ... Travel Risk Specialist to join the Corporate Security Global Travel Risk program .This position will be responsible for facilitating safe and secure business travel… more
- The George Washington University (Washington, DC)
- …retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit https://hr.gwu.edu/benefits- programs . ... medical education and has grown to include highly ranked programs in the health and biomedical sciences. With dozens...the tracking of the project and study timelines in program management software, Mondays.com. Assists the PI with the… more
