- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- BioAgilytix (Durham, NC)
- …and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... checks.Establish automated data validation and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance, handling and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory requirements is ... ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory … more
- Genmab (NJ)
- …driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, ... inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as...as a Data Standards or Clinical Systems Lead as needed. Regulatory and Submission SupportContribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... quality and integrity initiatives.Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. ... advanced knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …legal regulatory or compliance experience is required Technology and data analytics experience in a pharmaceutical or medical device compliance function is ... the Ethics & Compliance (E&C) Monitoring & Auditing function, prioritizing data analytics, trends, and insights in alignment with evolving government expectations,… 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 ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Aequor (Swiftwater, MN)
- …LIMS system. Maintenance support will include supporting Business Administrators in, updating master data for new and existing products, updating master data for ... role will support the creation and updating of master data to support the site transition to toa new...- Ensure that the LIMS complies with all relevant regulatory standards - Support the business in the creation… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust… more
- Merck & Co. (South San Francisco, CA)
- …Research and Development Sciences IT (RaDS-IT) of our Company is seeking a Lead Data Scientist for Representation Learning.Our team is a diverse collection ... stability, function, and interaction.Oversee the integration of structural biology data into machine learning models to improve predictive capabilities.Foundation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug ... Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents… more
- Formation Bio (New York, NY)
- …and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing ... biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Durham, NC)
- …and schedules project/work meeting the criteria established by site objectives.Support & lead Utility equipment related projects, scope including but not limited to ... groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with contractors, vendors, or other third-party… more
- Merck & Co. (Rahway, NJ)
- …Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory , and Quality.As part of Our Company's Manufacturing Division, ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …in DS manufacturing operations (cell culture and purification) Strong understanding of regulatory requirements and inspection readiness Ability to lead without ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs… more
- Genmab (NJ)
- …Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role ... development of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft… more
