- Takeda Pharmaceuticals (Boston, MA)
- …with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. ... and interpretation of experiments in compliance with appropriate global regulatory guidance. + Effective and independent management of both...minimum requirements should be noted.)_ + Advanced academic degree ( PhD or MD/ PhD ) + 5+ years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages ... + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… more
- Bristol Myers Squibb (Cambridge, MA)
- …translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to ... and disease scientists and BMS members from clinical, medical, commercial, regulatory and diagnostics as well as engage external academic collaborators/Key opinion… more
- Pfizer (Cambridge, MA)
- …result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and ... analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects. + Provide planning… more
- Bristol Myers Squibb (Cambridge, MA)
- …oncology. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external ... in high quality scientific, technical or medical journals. **Qualifications** : + PhD degree in a relevant field (eg molecular biology, cancer biology, human… more
- Guidehouse (Boston, MA)
- …work experience excluding internships, co-ops, or fellowships; **Or** Completing a PhD degree in electrical or power systems engineering from an accredited ... (1+) plus year directly relevant Graduate Assistant/Research work with relevant PhD research/course work experience + **Managing Consultant -** Bachelor's degree in… more
- Bristol Myers Squibb (Cambridge, MA)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy for the ... DSUR, etc. to support clinical trials and global registrations. Interacts with regulatory authorities to address questions as needed. + Support clinical assets for… more
- Bristol Myers Squibb (Cambridge, MA)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Merck (Boston, MA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide clinical… more
- Cambrex High Point (Waltham, MA)
- …with 8+ years of experience, an MS with 5+ years of experience, or a PhD with 1+ years of experience in analytical chemistry within the pharmaceutical industry. The ... etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality control testing are preferred.… more