- MD Anderson Cancer Center (Houston, TX)
- …will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. They will oversee a team of ... regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols,… more
- Takeda Pharmaceuticals (Austin, TX)
- …authority. + Thorough understanding of regulatory guidelines related to global submissions and submission content (eg, FDA /EMA/PMDA regulations; ICH guidance; ... best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and Marketed… more
- Merck (Austin, TX)
- …, including IND, NDA, BLA, and MAA applications. + Ensure that regulatory submissions meet the requirements of FDA , EMA, and other health authorities, ... **Job Description** The Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance… more
- Takeda Pharmaceuticals (Austin, TX)
- …as lead writer for important regulatory response documents and key components of regulatory submissions . + The Associate Director , Medical Writing is seen as an ... bring life-changing therapies to patients worldwide. Join Takeda as a Associate Director Medical Writing where you will be responsible for medical writing activities… more
- Danaher Corporation (Dallas, TX)
- …report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing ... role, you will have the opportunity to: + Lead regulatory submissions , including pre-market applications, product registrations, post-approval updates, by ensuring… more
- Merck (Austin, TX)
- **Job Description** **Position Title** - Director / Principal Scientist, Regulatory Compliance **Department** - Device Quality & Regulatory **Brief Description of ... and analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory **Location** - Remote, Preference… more
- Takeda Pharmaceuticals (Austin, TX)
- …strategy for key clinical and regulatory documents and regulatory submissions ; guides medical writing document preparation, including coordination of assignments ... key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.… more
- Houston Methodist (Houston, TX)
- …coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical ... Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on… more
- MD Anderson Cancer Center (Houston, TX)
- …are the lead, in collaboration with CRG Managers and the CRG Director . Coordinates strategies to enhance collaborations between investigators and clinical or ... execution. **DATA MANAGEMENT & EDUCATION** Works closely with CRG Managers and CRG Director in the development of novel data management tools to improve data quality… more
- General Dynamics Information Technology (Fort Sam Houston, TX)
- …the PI + Coordinates 1 to several simultaneous projects for the PI/ director ; confers with investigator on experimental design; provides instruction on various ... systems, specifically which includes the current accounts tracking systems, publication submissions , purchase orders, credit card purchases, and preparation of forms… more