- 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
- 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
- BeOne Medicines (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
- Bristol Myers Squibb (San Diego, CA)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . Senior Manager of Regulatory Project Management will plan, execute ... may be assigned. + Project Planning and Execution of Regulatory Submissions (eg, IND, CTA , NDA, MAA,...and Execution of Regulatory Submissions (eg, IND, CTA , NDA, MAA, IMPD, simplified dossiers, briefing packages, RFI,… 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
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Biostatistics Sr Manager **What you will do** Let's do this. Let's change the world. In this ... the clinical development environment with the supervision of more senior staff. **Accountabilities** *Provide dedicated support for Exploratory Biostatistics… 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