- Eisai, Inc (Nutley, NJ)
- …team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, relational ... Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong organizational skills with ability to effectively manage and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summar y : The Manager , Data Management is accountable for end-to-end delivery of clinical data ... studies. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry… more
- Aequor (Piscataway, NJ)
- Two new Regulatory Manager requisitions are about to go live in the system; one based in Princeton, NJ, and the other in San Diego, CA. Job Title: Regulatory ... Publishing Manager I Duties The Manager /Sr. Manager...This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports… more
- Genmab (NJ)
- …inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as needed.Regulatory and Submission SupportContribute to ... Director, External Data Quality Management, is a strategic leadership role within Clinical Data Management. This individual is accountable for driving the strategy,… more
- Aequor (San Diego, CA)
- The Manager , Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level ... publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …ability Ability to navigate PA's in rapidly developing market Health Systems and/or Institutional Account experience is preferred Clinical approach ... in health care settings and major academic and large community health systems . The Specialty Field Sales Representative also assists their target physicians with… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Internally, the Ecosystem Portfolio Specialist reports to the Ecosystem Business Manager . The Ecosystem Portfolio Specialist also must work collaboratively work with… more
- Merck & Co. (North Wales, PA)
- …Director, GPAM, the core responsibility of this Value and Implementation Project Manager role will be direct management of Project Managers, including understanding ... to effectively drive their team's strategy .- The staff manager will be expected to monitor quality of project...major corporate change projects can relate to optimizing capabilities, systems and operations, or improving the functioning of teams… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Novo Nordisk Inc. (Toms River, NJ)
- …current co-promotion partners. Internally, the DCS I report to the District Business Manager of the specific sales territory. The DCS I also interact and ... of territory customer groups and affiliations such as IPAs, Medical Groups, Health Systems , and Local Clinics and uses this to identify business opportunities and… more
- BioAgilytix (San Diego, CA)
- …studies in biological matrices using LC-MS/MS, supporting preclinical and clinical development across multiple modalities. The remaining 5% will involve ... and MHLW GLP regulatory requirements; proficient with LC/MS/MS, HPLC, ELISA systems and all laboratory equipmentDemonstrated experience in a supervisory role leading… more
- Aequor (Waltham, MA)
- …documents/forms/records are authorized to facilitate movement of cell product to clinical sites Support Manufacturing to collect and monitor key performance ... preventive actions. Suggest the development, implementation, and maintenance of quality systems , processes, and procedures related to GMP operations to mitigate… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise operational procedures,… more
- CareOregon (Portland, OR)
- …Utah, Idaho, Arizona, Nevada, Texas, Montana, or Wisconsin. Job Title Quality Assurance Manager , Clinical Systems Requisition # 25017 Exemption Status Exempt ... Management Level Manager Direct Reports Registered Nurse - Clinical ...Director in long- and short-term quality planning. + Assure clinical systems align with regulatory and contractual… more
- Touro University (Albuquerque, NM)
- Overview The EHR/ Clinical Systems Manager is responsible for overseeing and supporting the Touro College of Dental Medicine (TCDM) health information ... (EHR) system. Reporting directly to the Senior Director of Clinical Systems at Touro's New York campus,...Responsibilities include but are not limited to: + Administrative manager for axiUm at the New Mexico Campus. +… more
- CTG (Richmond, VA)
- **CTG is seeking to fill a Manager of Clinical Communication Systems opening for our client in Richmond, VA.** **Location:** Richmond, VA (hybrid remote) ... least two (2) years of supervisory or leadership experience. + Experience with clinical systems and workflows strongly preferred. + Additional preference for… more
- Houston Methodist (Houston, TX)
- …responsible for effectively managing the IT applications and support functions for clinical or business systems . This position effectively manages business ... definition, design, acquisition and implementation of new and modified systems for assigned departments. The Manager IT...to effectively apply project management processes + Understanding of clinical or business systems and workflows +… more
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