- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments and associated documents ( writing of ICF, DM ... external investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The PositionThe Deviation Investigator-Writer is responsible for investigating and writing of deviations to the manufacturing process and other operational ... is responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory… more
- Aequor (Parsippany, NJ)
- …manipulation of large datasets, negotiation/conflict resolution. System Implementation and report writing .- Revitas/Flex Medicaid and advance Microsoft Excel ... manipulation of large datasets, negotiation/conflict resolution. System Implementation and report writing .Specialized or Technical Knowledge, License, Certifications… more
- Aequor (Thousand Oaks, CA)
- …of statistics, etc.) Demonstrated skills in the following areas: Problem solving and applied engineering. Basic technical report writing . Verbal communication ... Information Systems is a plus Demonstrated strong communication and technical writing skills Strengths in facilitation and collaboration / networking Experience in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to solve complex study problems. Responsibilities Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, ... Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including...globally by providing input for the interaction or by writing the interaction document. May participate in meeting or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supervision to solve complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical ... Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies...globally by providing input for the interaction or by writing the interaction document. May participate in meeting or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from a physician's perspective- May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF ... (eg, response to HAs, briefing book, etc.) in conjunction with Medical Writing - Leads scientific components of IM (Investigators Meeting) and SIV (Site Initiation… more
- Merck & Co. (Durham, NC)
- …to ensure compliance with all global and regulatory standards. Develops and report to senior leadership data analysis and metrics to ensure systems' compliance ... organization as needed. Prior knowledge and/or use of cGMPs, technical writing , data management collection, and analysis. Demonstrates an innovative mindset.… more
- Merck & Co. (Boston, MA)
- …and automation for weekly screening with knowledge in MOSAIC and writing protocols for Echo, Bravo, Hamilton and other automation instruments.Assay execution ... or Python and SQL is desirable.Tibco Spotfire (dashboard, visualization & report development) with solid foundation in data management and data governanceExperience… more
- Aequor (Thousand Oaks, CA)
- …and methodology. This person will lead study data collection, root cause analysis and report writing to inform design and apply sound HFE/UE knowledge and ... syringes 20% and 80% auto injectors. Manager would like to see writing samples if available. Successful candidate understands human factors engineering and has… more
- Merck & Co. (Washington, DC)
- …of international organizations that may impact company interests.The role will report to the Executive Director, Multilateral Engagement and Global Public Policy, ... as well as to senior executivesFluent in English, verbal and written. Excellent writing and communication skills with the proven ability to develop new, innovative… more
- Merck & Co. (Washington, DC)
- …background preferred. Experience in policy tracking, analysis of geopolitical risks, and report writing . Expertise in designing databases and spreadsheets, with ... specific expertise in creating and analyzing large data sets in Excel and efficient user-friendly digital tools. Ability to manage competing priorities, often in time-sensitive environments, with effective project management skills Demonstrated ability to work… more
- Merck & Co. (Rahway, NJ)
- …Director for Animal Health Global Public Policy and Multilateral Engagement will report to the Associate Vice President, Global Public Policy & Government Relations ... working with the multi-lateral organizations and the WOAH specifically on writing or advising on international standards.Demonstrated ability to identify strategic… more
- Merck & Co. (Rahway, NJ)
- …and preclinical-to-clinical translation in bioperformance of formulationsThe Director will report to the Executive Director of Biologics and Biopharmaceutics, have ... Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Must… more
- American Honda Motor Co Inc (Marysville, OH)
- …Solving / Root Cause Analysis - Complete problem-solving analysis, investigations, report writing , and containment/repair activity with speed while utilizing ... quality engineering principles.Develop Countermeasures and implement - Countermeasure with Safety, Quality, and Delivery viewpoint, based on investigation and analysis which could include a design change, a modification of a supplier part, or an in-house… more
- American Honda Motor Co Inc (Marysville, OH)
- …Key AccountabilitiesLead and Manage complex problem solving analysis, investigations, report writing , and containment/repair activity utilizing quality ... engineering principles (Complex Analysis) Perform technical in-depth analysis related to mass production processes to minimize customer concerns (Line Call Support) Identify reoccurring problems and conduct design problem analysis to solve the issues (24… more
- Merck & Co. (Rahway, NJ)
- …evaluations, and incident investigations.Completes industrial hygiene monitoring and associated report writing to include a prioritization of Industrial ... Hygiene (IH)-related risks and develops and assists with implementing corrective and preventive action plans.Reviews processes, facilities, procedures and management of change documents to assure conformance to recognized EHS regulations, standards and… more
- Merck & Co. (Rahway, NJ)
- …collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 10-15 ... Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …tools & key process indicators within the batch release area Evaluate, trend & report data for continuous improvement in the release process Performs all job duties ... move objects. Visual acuity to perform close activities such as: reading, writing , and analyzing; and to determine the accuracy, neatness, and thoroughness of… more
- Insmed Incorporated (San Diego, CA)
- …GxP stability protocols, interim reports, and reports for stability studies.Manage, report , and trend stability data in JMP software and/or Labware LIMS. ... to drug substance and drug product stability testing.Strong technical writing , attention to detail, organizational, and excellent analytical skills.Excellent… more
