- BioAgilytix (Durham, NC)
- …and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... sharing between systems, with a focus on operational efficiency and data integrity . Data Quality & Compliance Automation: Use Robotic Process Automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms ... release, data review and cleaning, database lock), to ensure data quality/ integrity and regulatory complianceEnsures that Data Management Plans are… more
- Twist BioScience (South San Francisco, CA)
- …biomanufacturing operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective ... LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and ensure the accuracy, integrity… more
- Merck & Co. (Durham, NC)
- …products. For over a century, our success has been propelled by ethical integrity , forward momentum, and an inspiring mission to achieve new milestones in global ... Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality and… more
- Insmed Incorporated (San Diego, CA)
- …is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data analysis, problem-solving, ... our core values of collaboration, accountability, passion, respect, and integrity , we aim to foster an inclusive, diverse, and...(internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… more
- Merck & Co. (North Wales, PA)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
- Merck & Co. (Rahway, NJ)
- …collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality, completeness , and integrity of ... execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team… more
- Merck & Co. (Rahway, NJ)
- …develop the next medical breakthrough. Our Company's success is backed by ethical integrity , forward momentum, and an inspiring mission to achieve new milestones in ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technological and data innovation, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will ... (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked with providing… more
- Insmed Incorporated (San Diego, CA)
- …observations and development of adverse trends) to ensure patient safety and data integrity .Supports strategic direction with cross functional working groups to ... our core values of collaboration, accountability, passion, respect, and integrity , we aim to foster an inclusive, diverse, and...and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and… more
- Merck & Co. (Rahway, NJ)
- …drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data , ensuring data completeness and integrity , and ultimately ... further study of marketed compounds.In executing these duties, the Director will: Lead a cross-functional team including Clinical Scientists in endeavors ranging from… more
- Merck & Co. (Durham, NC)
- …advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with site commercialization efforts ... sites, Procurement, Raw Material & Component Suppliers Develop effective data analytics methodologies, including statistical process control, deepening process… more
- Repligen (Rancho Dominguez, CA)
- …are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at ... a Subject Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility… more
- Merck & Co. (Chicago, IL)
- …Affairs (GCSA)Initiates discussions with SLs and/or potential investigators that include scientific/ data exchange within our AOI to determine the alignment with our ... patient enrollment and retention efforts to achieve study milestones.Protocol lead responsibilities in collaboration with GCTOAddresses questions from investigators… more
- Formation Bio (New York, NY)
- …critical periods. Leverage AI-driven tools and automation to improve efficiency, data integrity , and decision-making processes. Communication & Cross-Functional ... planning for major program decisions. Synthesize technical, financial, and operational data to drive decision-making. Manage ambiguity by proactively identifying … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe purpose of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In ... addition, this role will lead the forecasting process supporting the Business Development team...leader for the organization who provides strategic guidance and data -driven insights. Collaborates with and influences franchise teams and… more
- Eisai, Inc (Boston, MA)
- …due to Alzheimer's disease (AD) or mild AD. The Area Business Leader (ABL) will lead a team of Neurology Account Specialists (NAS) that are part of a diverse team ... aspects of Alzheimer's disease and the competitive landscape in which they will lead . Additionally, the ABL will be responsible for ensuring their NASs educate… more
