- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & ... audits and inspections by providing technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all… more
- BioAgilytix (Durham, NC)
- … regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy requirements.Build and manage security operations, including incident response, threat ... Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical … more
- Eisai, Inc (Exton, PA)
- …of assays, and- when appropriate- personally performing the assays and techniquesNegotiate service contracts with external providers. Assess and document CMO/CRO ... Help in identifying and implementing CAPAs.Help in the administration of external stability programs, ensuring regulatory compliance, adherence to protocol… more
- BioAgilytix (Durham, NC)
- …to do their best work and drive resultsExcellent customer service skills (internal and external )Working Environment:Primarily laboratory environmentExposure ... Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical … more
- Merck & Co. (Durham, NC)
- …intermediates and finished products.Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. ... Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services , Utilities and Validation. Position Description: The Senior Specialist,… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy ... maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders in the Business and Technical Units, including external suppliers.As required, participate in Regulatory Agency inspection activities.As ... business applications, laboratory instrument systems, manufacturing automation systems and data analysis packages.Endorse and build Quality Management System elements… more
- Lundbeck (New York, NY)
- …and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers ... Leadership - Ability to use digital tools and apply customer and data -based insights to build opportunities, develop strategy & tactics and prioritize resources… more
- Merck & Co. (Rahway, NJ)
- …the organization to ensure the timely and cost-effective procurement of materials, services , and equipment critical to the success of our capital projects, thereby ... with Global Capital Procurement Category teams. Engage in internal and external governance activities to exert procurement influence, ensuring consistent application… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …forums.Evaluate risks and mitigation strategies collaboratively with internal and external stakeholders.Identify and assess potential suppliers, manage RFI/RFP and ... with Quality, Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for… more
- Eisai, Inc (Nutley, NJ)
- …development and the communication of clinical, real-world, health economics outcomes data . This role primarily focuses on late-stage pipeline and marketed products, ... execution of customer centric research activities and development of external communication materials. The Director facilitates coverage, reimbursement and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/ data process mapping activities.Execute, own, assess and participate in the ... in a heavily regulated pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom… more
- JPMorgan Chase (Columbus, OH)
- Join our team as the CCB Regulatory & External Data Services (REDS) Product Owner. In this position you will be responsible for managing reporting that ... data filings required to comply with and fulfill regulatory , financial, external and legal obligations which...Python, SQL, AWS, Java Chase is a leading financial services firm, helping nearly half of America's households and… more
- Citigroup (New York, NY)
- …of data controls. Ensure adherence to internal policies such as CDGP (Citi Data Governance Policy) and external regulatory requirements for data ... institutions with a broad range of financial products and services , including consumer banking and credit, corporate and investment...against frameworks that improve the quality and value of data to meet regulatory commitments and enhance… more
- Bristol Myers Squibb (Devens, MA)
- …+ **Ensure data governance, security, and compliance with internal and external regulatory requirements.** + **Troubleshoot data -related issues and ... data warehousing solutions (eg, Snowflake, Redshift).** + **Familiarity with GMP data requirements and regulatory expectations for data integrity.** +… more
- TD Bank (Mount Laurel, NJ)
- …+ Analyzes and documents metadata to support adherence to internal requirements and external regulatory requirements + Manages data risk across lifecycle ... more specific details for this role. **Line of Business:** Data & Analytics **Job Description:** The Data ... related risks in day-to-day activities, operations, products and services within the Business, to ensure activities are within… more
- Synchrony (Dallas, TX)
- …+ Responsible for interpreting and delivering regulatory reporting requirements, external requests and corresponding data extraction from multiple data ... warehouses including data validation to support critical Regulatory and other internal reports. + Support the establishment and ongoing enhancement of credit… more
- AbbVie (Worcester, MA)
- …AbbVie Worcester site, Data Integrity subject matter expert during internal and external regulatory inspections related to data integrity. + Ensure ... the end-to-end product lifecycle and various departments in alignment with relevant regulatory regulations and guidelines. + Implement data governance framework… more
- J&J Family of Companies (Spring House, PA)
- …**We are searching for the best talent for Principal Scientist, External Animal Welfare & Regulatory Compliance in Spring House, ... if approved by the Company. **Purpose:** The Principal Scientist, External Animal Welfare & Regulatory Compliance will...for 3Rs advancement. + Review in vivo studies veterinary data and provide guidance on clinical case management for… more
