- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution ... of global investigational submissions and manages lifecycle regulatory activities for assigned Clinical Trial Application projects in alignment with the Global … more
- Houston Methodist (Houston, TX)
- …communication, managing stakeholder(s) expectations. + Executes CTA requests from Senior Legal Contract Manager 's assigned internal research clients and ... At Houston Methodist, the Senior Legal Contracts Manager position is...of the parties. **QUALITY/SAFETY ESSENTIAL FUNCTIONS** + Identifies legal, regulatory and operational issues in CTA review… more
- Takeda Pharmaceuticals (Boston, MA)
- …and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager . The Senior CTA will collaborate with ... with established protocols under the general supervision of the CTA Manager . + Collaborate with Clinical Operations...strategy as defined in the Clinical Development Plan. The Senior CTA will provide support for critical… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA , NDA or BLA, MAA). - RAC ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Chicago Transit Authority (Chicago, IL)
- Manager , Maintenance - Rail - ( 2500003U ) **Description** **SALARY** $110,872.59 **POSITION SUMMARY** Manages and implements required rail fleet maintenance to ... and determines appropriate course of action to correct problem areas. + Implements CTA procedures for proper transport, storage, and disposal of solid and hazardous… more
- BeiGene (San Mateo, CA)
- **_General Description:_** The Senior Manager , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) to conduct signal ... Travel: Less than 10% **Supervisory Responsibilities:** The position has no direct reports. The Senior Manager , Safety Scientist is part of a team that performs… more
- University of Miami (Miami, FL)
- …Miami, FL CORE JOB SUMMARYThe Regulatory Analyst 3 - UHealth assists the Regulatory Manager and/or Director of Regulatory with the day-to-day operations ... recommend, and implement + corrective and preventive actions for regulatory with the guidance of senior leadership....+ Draft Budget (if applicable) + Clinical Trial Agreement ( CTA ) + Patient documents (if applicable) + Recruitment materials… more
- Orchard Therapeutics (Boston, MA)
- …increasing level of study manager responaibilities with guidance from the study manager . The CTA will also be responsible for supporting individual studies, ... Location: Boston Reporting to: Senior Director, Clinical Operations Job Summary Orchard Therapeutics...the Director of Clinical Operations, the Clinical Trial Associate ( CTA ) will be responsible for providing project administrative and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …program(s) forward from pre-IPA nomination through BLA application, including multiple pre-IND/ CTA molecules under development and new indications and life cycle ... program therapeutic area development strategies inclusive of research, clinical, regulatory , supply (includes tox, clinical and commercial materials) and commercial… more