- ThermoFisher Scientific (Boston, MA)
- …technical documents, including method SOP, study protocol, technical report, and other regulatory agency facing documents + Be a key Subject Matter Expertise (SME) ... to perform the job **(comparable 6+ years')** + OR PhD and previous experience that provides the knowledge, skills,...Abilities:** **Must Have** + Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concepts +… more
- Sanofi Group (Cambridge, MA)
- …Regulators; + You will drive the effective closure of action plans originating from regulatory inspections and internal audits **About You** + Master or PhD in ... regulations and shape Healthcare ecosystem. + Ability to translate how the regulatory , societal and technological changes in collecting and processing personal data… more
- Tufts Medicine (Boston, MA)
- …Core Laboratory. The Core Laboratory Director's responsibilities include technical, regulatory , and clinical oversight of various core laboratory disciplines, such ... and appropriate board certification (DABCC or NRCC), while physicians (MD or MD/ PhD ) should have board certification in Clinical Pathology. **How you'll transform… more
- Amgen (Cambridge, MA)
- …protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents + Lead project teams and/or project sub-teams to meet ... 5 years of Scientific experience; Or + Doctorate degree PhD OR PharmD OR MD and 2 years of...and validation. + Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience… more
- Cytel (Cambridge, MA)
- …with key safety related activities in drug development, including regulatory submission/ISS, periodic safety reporting, Data Monitoring Committees, Health Authority ... interactions etc. Strong awareness of regulatory guidelines including ICH and GCP, and experience with CDISC standards. + Strong methodological skills and an… more
- Sanofi Group (Framingham, MA)
- …Responsible for internal documentation and preparation of technical reports required for regulatory documents. May support authoring of regulatory filings + ... technical lead in cross-site, cross-functional teams **About You** **Education and Experience** : + PhD with 2 years, or Master with 5 years, or Bachelor with 7… more
- Takeda Pharmaceuticals (Boston, MA)
- …advancing the broader IBD portfolio. **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** + PhD degree in a scientific discipline with 10+ years' experience , orMS ... and genetics discovery and development as demonstrated by publications, regulatory submissions and/or national or international presentations + Excellent… more
- Burns & McDonnell (Newton, MA)
- …and economic dispatch associated with congestion management scenarios. + Evaluates regulatory conditions and risks by applying NERC, FERC, and Regional requirements, ... assessments that evaluate impacts associated with rules implemented by regulatory agencies. + Develops and conducts detailed financial analysis...may be substituted for 1 year of experience. + PhD in Engineering may be substituted for 2 years… more
- Takeda Pharmaceuticals (Boston, MA)
- …Communications and external content contributors **BASIC QUALIFICATIONS:** + Advanced degree ( PhD , PharmD, or equivalent) in a scientific discipline (preferred) or a ... and publication planning, including ideas for sub-analyses + **Compliance and Regulatory :** Excellent understanding of regulatory , compliance and legal… more
- Merck (Boston, MA)
- …in the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies) + Responsible for managing, coaching, and mentoring Clinical ... talent pool within the pediatric section. **Education:** + Advanced degree (MD, MD/ PhD ) with at least 8 years' experience in vaccine clinical development. Prior… more