- Ochsner Health (New Orleans, LA)
- …today!** This job independently manages and coordinates all aspects of the clinical trials for selected departments and populations according to regulatory ... - 3 years of relevant research experience in a clinical setting, OR 2 years of relevant research experience... trials. + Ability to coordinate and oversee the regulatory processes as they relate to the evaluation, initiation,… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... implementing global regulatory strategies with focus on America's and the clinical , and non- clinical disciplines. Ensures timely preparation of organized and… more
- Merck (Rahway, NJ)
- …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MS with 10+ years of experience. + Ph.D. with… more
- Takeda Pharmaceuticals (Boston, MA)
- …product strategy across Takeda's development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. ... R&D technology or digital product leadership roles, with deep expertise across Clinical , Regulatory , and Pharmacovigilance domains. + Strong understanding of… more
- Edwards Lifesciences (Irvine, CA)
- …Edwards. Providing exceptional legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this role will also ... guidance and support to Edwards' leaders on medical device commercial, clinical , regulatory , quality and reimbursement related legal matters, including… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee… more
- Pfizer (Cambridge, MA)
- …and business experience providing an understanding of the processes associated with clinical , regulatory and marketing operations. + Capability to provide ... this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and… more
- Houston Methodist (Houston, TX)
- …Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical ... and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory compliance. Meets with study… more
- Otsuka America Pharmaceutical Inc. (Charleston, WV)
- …them into clinical development plans to support drug development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study ... performed and presented. Author PK reports that are integrated into clinical and regulatory documents. + Lead development of ** clinical pharmacology**… more
- Caris Life Sciences (Phoenix, AZ)
- …for internal stakeholders and research staff. + Maintain awareness of changes in clinical regulatory processes and assist in the development of new processes ... submitting documents to Institutional Review Boards (IRBs). + Strong understanding of clinical research documentation, clinical regulatory processes, and… more
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