- Takeda Pharmaceuticals (Los Angeles, CA)
- …Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Help document issues with immediate corrections and ... for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. The… more
- Robert Half Technology (Torrance, CA)
- …enhance operational efficiency. * Manage IT-related audits and ensure readiness for regulatory reviews. * Support document capture and management systems, such ... * Develop and enforce IT policies and procedures, ensuring compliance with regulatory requirements. * Conduct risk assessments and prepare comprehensive reports for… more
- BeOne Medicines (San Mateo, CA)
- …checks on analysis results to ensure data integrity and compliance with internal and regulatory standards. + Document QC processes and findings. + Data Curation ... and Engineering: + Modify large datasets to prepare for analysis. + Utilize tools such as R and Phoenix WNL to streamline workflows. + Support assembly of relevant ClinPharm datasets. **Supervisory Responsibilities:** + Assist with and/or lead internal… more
- BeOne Medicines (San Mateo, CA)
- …knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks. + Experience with document management and Regulatory Information Management Systems (RIM). **Travel:** ... **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle… more
- Belcan (Oxnard, CA)
- …cross-functional teams, including engineering, quality assurance, project management, and regulatory affairs, to ensure effective document management throughout ... Management) or equivalent experience. Ops Coordinator Job Duties * Maintaining document control systems, coordinating document reviews and approvals, and… more
- Actalent (Moorpark, CA)
- Job Title: Document Control SpecialistJob Description We are seeking a detail-oriented and proactive Document Control Specialist to join our team at a leading ... with cross-functional teams to ensure SOPs reflect current practices and regulatory requirements. + Initiate, track, and close change control requests related… more
- Atlas (Los Angeles, CA)
- …they stay on track and in compliance with design, technical, and regulatory standards. **Key Responsibilities:** + ** Document Management:** + Maintain and ... support reporting and compliance. + **Issue and Condition Management:** + Track, document , and resolve project issues and site conditions to ensure project progress… more
- CVS Health (Sacramento, CA)
- …and every day. Oversees the day-to-day management and leadership of the plan document drafting team. Develops and coaches the team to effectively manage client ... a consistently high-quality client experience within the department while maintaining regulatory compliance. This role directly manages 10-12 colleagues and provides… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- J&J Family of Companies (Santa Clara, CA)
- …United States of America **Job Description:** Johnson & Johnson is hiring for a ** Document Control Specialist II** **- Shockwave Medica** l to join our team located ... Overview** In compliance with FDA, European MDD/MDR & ISO regulations, the Document Control Specialist II will perform work exercising judgment with only general… more