- Regeneron Pharmaceuticals (Cambridge, MA)
- …of clinical development, including protocol development, data collection and analysis , preparation of regulatory submissions including Investigational New ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for… more
- ThermoFisher Scientific (Boston, MA)
- …& related activities. + Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + ... full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical… more
- Pfizer (Cambridge, MA)
- …in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, ... manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful… more
- Amgen (Cambridge, MA)
- …data to support drug substance and drug product development, including purity analysis , chiral purity and structure elucidation using mass spectrometry + Manage ... and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and develop a small...3 years of Scientific experience; Or + Doctorate degree PhD OR PharmD OR MD **Preferred Qualifications:** + … more
- AbbVie (Cambridge, MA)
- …drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions, and responding to ... position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for… more
- The MITRE Corporation (Bedford, MA)
- …and Analytics Division. In FINLab, our CompFi scientists provide expert analysis and consulting to our Federal Government clients in transforming their ... technologic and regulatory processes to enhance the safety, stability, and security...Tech and Supervisory Tech, Financial Analytics, Market Modeling and Analysis . Job Description: + Develop innovative, multidisciplinary approaches for… more
- Bristol Myers Squibb (Cambridge, MA)
- …biology, immunology, biologics, translational research, and document preparation for regulatory health authorities. This includes an understanding of the impact ... + **Analytical Skills:** Skilled in critical thinking and scientific data analysis , offering guidance and data-driven recommendations. Proven ability to objectively… more
- Sumitomo Pharma (Cambridge, MA)
- …with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities** + Serve ... statistical design, authoring statistical sections of study protocols and Statistical Analysis Plans (SAPs), and supporting trial design, including sample size… more
- Merck (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… 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