- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Bristol Myers Squibb (Princeton, NJ)
- …Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC , Commercial Manufacturing, etc.) to define and ... seeking to optimize PDs impact within the broader portfolio. + Influences CMC regulatory strategies and critically reviews relevant documents, including but… more
- Abeona (Cleveland, OH)
- Position Overview We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple ... commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, ... employer. **Job Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Job Title**… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- ThermoFisher Scientific (Wilmington, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Oversight Respiratory Trials Team.**… more
- ThermoFisher Scientific (Wilmington, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher...in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing… more
- MD Anderson Cancer Center (Houston, TX)
- …and preclinical research protocols. Work practices must be in compliance with regulatory requirements. The Senior Radiochemist will also provide guidance and ... the public. **SUMMARY ** The primary purpose of the Senior Radiochemist position is the responsibility for the safe...critical inputs on new ideas and approaches with Lab Manager or Director. ** Regulatory Responsibilities** * Follows… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development** , as a ** Senior ** **As** **sociate Scientist** . The successful candidate will contribute to ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more