- Bristol Myers Squibb (Cambridge, MA)
- …Leadership organization are strategic-thinking, problem-solving, and action oriented scientific leaders who bring drug development and commercialization insights ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. + Ability to broadly… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory requirements and guidelines. + Knowledge of other relevant regional regulatory nuances and requirements. + Knowledge of scientific principles and ... and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead,… more
- J&J Family of Companies (Danvers, MA)
- …Officer. The MSO will build clear and strong relationships between Medical Affairs , R&D, Quality, Regulatory , Clinical, Epidemiology to allow for proactive ... and safety communications. + Stakeholder Collaboration: Work closely with Medical Affairs , R&D, Quality, Regulatory , and other cross-functional teams to… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... strategy and plan for the assigned molecule(s)/indication(s) + Responsible for scientific leadership and execution of clinical studies and delivering on innovative… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Takeda Pharmaceuticals (Boston, MA)
- …within the CoE of Global Medical. + Provides innovative thinking and scientific expertise into peri- and post-approval research programs and real-world evidence ... of a strategy for all study types within Global Medical, ie Medical Affairs Sponsored Studies (MACs). Also, develops Areas of Interest (AOI) for Collaborative… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... data from various sources including non-clinical, clinical, post-marketing and scientific literature. + Conduct signal detection, monitoring, evaluation, interpretation,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more