- Novo Nordisk Inc. (West Lebanon, IN)
- …career. Are you ready to realize your potential? The PositionThe Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assist the Vice President and Sr. Director (where applicable) in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal ... outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator -sponsored studies (ISS) and provide comments to RGC Chair Attend… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders. Relationships This position will report to ... Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) ... Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a US IIS Review Committee, for ... medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 studies (depending on assignment) with ... other site personnel as needed- Study-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical monitoring- For… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 - Phase 3 studies (depending ... and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoringFor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …indications/projects related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, ... and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in… more
- Tris Pharma (Monmouth Junction, NJ)
- …GCP and is the primary liaison with Health Authority and Partners during internal audits and Health Authority inspections.Conducts audits at Clinical trial sites and ... in both Pharma and Medical DevicesExperience in developing SOPs , reviewing internal clinical, regulatory, and medical processes to ensure they are accurately… more
- Merck & Co. (North Wales, PA)
- …forms, data analysis plans, and final reports/publications.Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols ... to more junior members of the team.Present research plans and results to internal review and governance committees; to external experts and agencies (eg UK HSA)… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (eg, Medical, Marketing, and Sales), and decision makers in ... and study committee members for DSI clinical research programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to team members and track them to completionFollow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.Perform ... as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).Maintains various databases of… more
- Merck & Co. (North Wales, PA)
- …and productivity) for all deliverables and services. - Experience working with internal (Clinical Sciences, BARDS, GCTO, R&D IT) and external (functional service ... providers, labs, investigator sites, etc.) stakeholders to deliver products and services...to maximize delivery of services with measurable outcomes.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting… more
- Merck & Co. (Rahway, NJ)
- …and CRA on data findings and resolve via data queries with the Investigator siteTo evaluate protocol deviations for effect on data analysis and interpretationLock ... countries, while our products are available in some 150 markets.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Writer is expected to develop and maintain a strong network of internal relationships with global and local cross-functional study teams. The Principal Medical ... Clinical study protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Responses to requests from regulatory agencies and ethics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from ... include: Clinical study protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of regulatory risks and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents ... for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the… more
- Eisai, Inc (Toledo, OH)
- …on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal /external projects as they arise. The impact that a MSL will have on the ... relationship Research Support Facilitate review and follow up of submitted Investigator -Initiated Studies (IISs) and assist with Eisai sponsored trials. The MSL… more
- Insmed Incorporated (San Diego, CA)
- …team.Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and SAE reports in collaboration with Clinical ... potential product evaluation, and due diligence.Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory… more
- New York State Civil Service (Tupper Lake, NY)
- …Agency Justice Center For The Protection Of People With Special Needs Title Internal Investigator 1 (Justice Center) / Trainee 1/2 Occupational Category ... completion of a two-year traineeship leads to appointment as an Internal Investigator 1, SG-18.)OR six years* of investigative experience** for appointment to… more
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