- Sanofi Group (Cambridge, MA)
- …goals and functional expertise across other EGDS functions and EGDS TAs. ** Quality Assurance of Statistical Approaches:** + As a group head of biostatistics ... digital biomarkers.Cultivaterepresentation of Sanofi at key industry conferences (eg DIA, FDA industry workshop) and academic forums. + Establish and maintain… more
- Takeda Pharmaceuticals (Boston, MA)
- …efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. **About the role:** ... the cross-functional interfaces with the statistics function. + Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design,… more
- Bristol Myers Squibb (Cambridge, MA)
- …to large user groups. + Regulatory Knowledge: Understanding of regulatory requirements and quality standards in the life sciences industry, such as GxP, FDA , ... and ISO standards. Preferred Qualifications: + Experience with LIMS and ELN platforms (eg Genedata, Dotmatics, Revvity, Sapio, Benchling, etc.). + Certification in Business Analysis (eg, CBAP, CCBA) or Project Management (eg, PMP). + Familiarity with data… more
- Medtronic (Danvers, MA)
- …team members to address production challenges and implement solutions. + Perform quality checks and ensure compliance with company and industry standards. + Assist ... troubleshooting. + Experience with GMP requirements and industry requirements for FDA regulated industries such as medical devices or pharmaceutical manufacturing +… more
- Medtronic (Boston, MA)
- …submit, and manage regulatory filings across global regulatory agencies based on FDA and EU submissions. Provide expertise on RF-related regulatory requirements and ... trends and provide guidance to internal stakeholders. Collaborate with R&D, Quality , and other teams to ensure product compliance throughout the lifecycle.… more
- North Coast Seafoods (Boston, MA)
- …the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... health care coverage, vacation and 401(k) to all full-time benefit-eligible employees. Employees also have access to the highest quality seafood at cost. more
- North Coast Seafoods (Chatham, MA)
- …the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... and 401(k) to all full-time benefit-eligible employees. Employees also have access to the highest quality seafood at cost. This is a full-time, nonexempt position. more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Knowledge and Skills:** + Strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ... design control process evolution to meet device regulations. + Collaborate with Quality , Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement + Work… more
- Sanofi Group (Framingham, MA)
- …industry techniques and develop cell culture subject matter expertise in an FDA -regulated setting. We are an innovative global healthcare company with one purpose: ... refine flux balance analysis (FBA) and metabolic flux analysis (MFA), providing high- quality experimental data to constrain and validate computational models + The… more
- Sanofi Group (Cambridge, MA)
- …high-touch role, you will assist patients and caregivers with accessing Sanofi's FDA -approved T1D therapy, facilitating insurance approvals for both the product and ... family with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral… more