- GE HealthCare (Boston, MA)
- …trials, at the heart of which are Imaging Technology Leads (typically PhD /MD/PGDip/MSc level) with subject matter expertise in imaging science and technology. In ... clinical sites + Author and review imaging sections of trial-facing and regulatory documents + Collaborate with R&D Digital colleagues in the development of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs),… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Sanofi Group (Cambridge, MA)
- …qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of leading an internationally dispersed ... of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... + BS + 18 years of experience; MS + 16 years of experience; PhD + 10 years of experience **Technical Skills/Competencies:** + Ability to propose and influence… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase...+ Education in a relevant field, for example a) PhD in a field such as (Bio)statistics, Physics, Electrical… more
- Sanofi Group (Cambridge, MA)
- …Our Medical function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to support patients' needs. ... You** **Education:** Advanced degree in a scientific discipline (MD, PhD or PharmD) **Experience:** + Significant immunology experience required (Gastroenterology… more
- Takeda Pharmaceuticals (Boston, MA)
- …development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency ... external compounds (alliances and in-licensing opportunities) + Primary interface with Medical Affairs team for strategy and to support of product commercial efforts… more
- Sanofi Group (Cambridge, MA)
- …+ You will co-author internal position papers with Legal and Government Affairs , representing Sanofi in industry advocacy efforts with Trade associations, and Data ... Regulators; + You will drive the effective closure of action plans originating from regulatory inspections and internal audits **About You** + Master or PhD in… more