- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt ... external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- AUROBINDO (Durham, NC)
- …Pharma USA, Inc. is committed to delivering a broad portfolio of quality , affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. ... Must be able to calculate, organize, and communicate results via standard data templates and reports. Experience in a cGMP laboratory and testing. Provide… more
- Cipla (Fall River, MA)
- …as a first or second language Ability to understand and analyze complex data sets. Knowledge of statistical packages is a plus. Knowledge of good manufacturing ... GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded and generic medicines. We are trusted by healthcare professionals… more
- Cipla (Hauppauge, NY)
- …qualifications and validations studies documents as per cGMP Ensure real time correct data entries in the system and on documents by reviewing the documents during ... About Cipla Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded, and generic medicines. We are trusted by healthcare professionals… more
- Eisai, Inc (Baltimore, MD)
- …the operational aspects of global regulatory submissions to produce high- quality , time-sensitive deliverables in accordance with agreed-upon submission timelines. ... submission planning and execution, including document compilation, publishing, and quality checks.Provide technical oversight and troubleshooting for eCTD submissions… more
- Cipla (Fall River, MA)
- …qualifications and validations studies documents as per cGMP Ensure real time correct data entries in the system and on documents by reviewing the documents during ... GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded and generic medicines. We are trusted by healthcare professionals… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee all engineering management including asset/reliability, data systems/automation and Commissioning/Qualification.Support the development and ... minimize downtime.Collaborate with cross-functional teams including Facilities, Finance, HR, Quality and Operations to ensure engineering support broader organizational… more
- Aequor (Houston, TX)
- …and corrective action guidance. Collaborate with cross-functional teams (Legal, E&C, IT, Quality , EHS, local HR and outside counsel) to ensure comprehensive and ... internal reporting and recordkeeping. Support efforts to gather and analyze investigation data to identify trends, risks, and areas for improvement, in collaboration… more
- Insmed Incorporated (NJ)
- …In this role, you'll have the opportunity to work cross-functionally with Quality , Clinical business teams, Regulatory, and external vendors to ensure validated ... third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and cybersecurity requirements.Drive continuous improvement of validation… more
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