- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director , ... Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a technical mentor and operations team… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Merck & Co. (North Wales, PA)
- …Alliances b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value ... quality value delivery across all aspects of the data value chain including but not limited to a)...Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a… more
- Merck & Co. (Rahway, NJ)
- …animal species. About the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of ... organization, from senior management to tactical execution- to understand customer master data management needs. With an increased focus on Commercial, Sales, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical Study ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Merck & Co. (Rahway, NJ)
- …compliance with MCAAS requirements, improving reporting mechanisms, and delivering high- quality insights for decision-making through validated data sources, ... Job DescriptionThe Director of Business Systems and Process Improvement leads...of Invoice and Purchase Order processing. This includes implementing data mapping, dashboards, and process improvements using tools such… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.May serve as the single regulatory representative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education:… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... attention to detail, clarity, accuracy and conciseness.Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)Proficient in analyzing data … more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (South San Francisco, CA)
- …and innovation as the head of a group responsible for delivering high quality characterization data to advance discovery programs from the high-throughput ... are seeking an exceptional and experienced leader in the role of Director of Biologics Analytical Characterization and Developability in the Protein Sciences… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... CMD strategy, including integration of new technology platforms, human biology, and data science, with a focus on uncovering novel biology in immuno-metabolism to… more
- Merck & Co. (Rahway, NJ)
- …in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical ... Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations, external data sharing, and authoring lay… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Durham, NC)
- Job DescriptionAs the Vaccine Automation Director , you will be the primary point of contact for the HPV IPT for all digital implementations, support, and ... the liaison between above site DMO and the site clients.- The Vaccine Automation Director works with the HPV IPT, Supply Chain, and Technical Operations site leads… more
