- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + Advanced knowledge and/or hands-on applications in ... integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. + Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. + Scientific… more
- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- ThermoFisher Scientific (Plainville, MA)
- …fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other regulatory authorities required. **Knowledge, ... Skills, Abilities** + Capable of writing reports, business correspondence, and procedure manuals. + Strong organizational skills; ability to prioritize and lead through complex processes/projects. + Ability to read, analyze, and interpret business periodicals,… more
- Children's Hospital Boston (Boston, MA)
- …Applies regulatory knowledge of agencies including The Joint Commission, DPH, FDA , and CMS. Qualifications: + Education: + Bachelor's degree in Nutrition ... & Dietetics or a closely related field required + Master's degree preferred + Experience: + Minimum of five (5) years of progressive dietetic experience in pediatric nutrition + Demonstrated experience in project management and staff leadership + Experience… more
- Tufts Medicine (Boston, MA)
- …academic program is nationally recognized with major awards funded by NIH and FDA for genome sequencing, real world data, and novel device development. Our Clinical ... and Translational Science Award program was just renewed by NCATS for seven years (22 years of continuous funding). **Who You Are:** + Board Eligible or Board Certified in Neonatal-Perinatal Medicine + Have a passion for teaching and eligible for academic… more
- Charles River Laboratories (Cambridge, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** + Bachelor's degree in biomedical… more
- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- Charles River Laboratories (Shrewsbury, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …needs (eg, orphan products, fast track, breakthrough therapies, PRIME) + Strong FDA and EMA experience required + Full functional knowledge of regulatory ... requirements (regulations, directives and guidance/guidelines) pertaining to the development and registration of drug products in multiple ICH regions + Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside… more