- Merck & Co. (North Wales, PA)
- …(GCTO) and Business Development (BD) to assess the operational and regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. ... within the metrics process Hands-on experience in the conduct and execution of regulatory digital health assessments Development of critical analysis and project… more
- Merck & Co. (Rahway, NJ)
- …and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career. - As ... intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory … more
- Merck & Co. (North Wales, PA)
- … requirements, internal standard operating procedures, and external regulatory requirementsEvaluates appropriateness of available software for planned analyses ... analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.May represent biostatistics in regulatory interactions… more
- Merck & Co. (Rahway, NJ)
- … analysis to provide meaningful insights for teams developing business cases and making investment decisionsAbility to guide and influence interdisciplinary ... Division IT spanning the LROP including Discovery, Clinical and Regulatory .This role also supports the SVP of the Chief...ability to act as strategic thought partner and trusted advisor to the businessSkilled in data analysis … more
- Option Care Health (Springfield, IL)
- …for promoting awareness and compliance with Company policy, advising on business initiatives, strategic objectives, changes in our regulatory environment ... order of importance and/or time spent)Act as a trusted advisor to our Business Teams providing strategic... business challenges and potential solutions including assisting business partners with the risk/benefit analysis .Partner with… more
- Merck & Co. (Rahway, NJ)
- …and unplanned statistical analysesPrepare compliant programming code for regulatory submissions including analysis /modeling datasets, tables, listings, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership team At least 12 years progressive leadership experience in data analytics, business analysis and services experience related to the life science ... insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety, integration of new/existing ... in the development of predictive and preventive maintenance programsExecutes functional business plans and contributes to the development of group or company… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (North Wales, PA)
- …oversight and creation of the Study Data Tabulation Mode (SDTM) deliverables for analysis and reporting and world-wide regulatory application submissions of drug ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project stakeholders.- Primary… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into growth opportunities that shape decisions and drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) ... status quo, proposing solutions, and driving approved implementation plans Leadership and strategic business partnership: Serve as a key advisor to the CMR… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX), experience in microbiological… more
- Merck & Co. (Rahway, NJ)
- …including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at … more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta- analysis (MBMA) and clinical trial simulations (CTS) into programs… more
- Merck & Co. (Rahway, NJ)
- …and characterization, scale-up and activities to support technology transfer and regulatory filings. They are responsible for the management and development of ... commercial supply sites and documented in technology transfer documents and regulatory filing submissions.The role maintains awareness of external factors, internal… more
- Merck & Co. (Durham, NC)
- …supervision and/or project/automation/IT support.Proven record of proficiencies associated with business analysis on small sized projects.-Strong hands-on MES ... goals.Provides training sessions to our Company personnel pertaining to MES requirements. BUSINESS EXPERTISE:Understands the fundamental business drivers for the… more
- Merck & Co. (North Wales, PA)
- …Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies (GCS), ... CLINICAL DEVELOPMENT:Lead working groups of SMEs to ensure proper analysis , improvement identification and creative solutionsSupport implementation and understanding… more
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