- Merck (Austin, TX)
- …+ 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. + MD or Ph.D./Pharm D with 7+ years of… more
- Pfizer (Collegeville, PA)
- …(Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... Description: Regulatory expert in the area of Biosimilar/BLA submissions...of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory ... user needs into technical requirements + Coordinate risk mitigation activities across clinical , regulatory , quality, and engineering functions + Perform safety… more
- Abbott (Maple Grove, MN)
- …/ Clinical Evaluation Reporting (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise ... and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related… more
- Abbott (Sylmar, CA)
- …Leads various study support groups and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use ... R&D, Quality Engineering, Product Performance Group, Risk Management) clinical - regulatory organization, and some interactions with principal investigators… more
- Ascendis Pharma (Princeton, NJ)
- …years within Medical Writing. Furthermore, you have: + Experience in authoring clinical / regulatory documents. + Excellent verbal and written communication skills ... across time zones. + Ability to understand, interpret and communicate data from clinical trials. + Proven ability to work with and lead cross-functional, global… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of the following tracks: + Clinical Operations & Program Management + Clinical Sciences + Regulatory Strategy + ** Regulatory Labeling & ... **In this program, you may experience:** + Drafting documents integral to clinical sites and regulatory submissions + Analyzing data from clinical studies in… more