- Cardinal Health (Boston, MA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg,… more
- System One (Devens, MA)
- …technical field (entry-level to 2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness in an ... + Perform safe, timely, and cost-effective production of pharmaceutical products that meet quality and regulatory standards. + Operate in an aseptic environment… more
- Takeda Pharmaceuticals (Boston, MA)
- … Quality Events, Serious Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP management, training ... of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with… more
- Sanofi Group (Cambridge, MA)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- System One (Devens, MA)
- …use of staff, materials, and equipment to meet production targets while maintaining product quality and safety. + Maintain full compliance with SOPs, FDA cGMPs, ... training. + Oversee documentation of production processes, ensuring alignment with all regulatory and company standards. + Act as a liaison between Production and… more
- Biomat USA, Inc. (Worcester, MA)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- Beth Israel Lahey Health (Burlington, MA)
- …general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research ... medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. +… more
- Sanofi Group (Cambridge, MA)
- …medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review and approval ... of regulatory documents, ensuring adherence to company standards and government/industry...skills. + Strong understanding of clinical trials processes and FDA approval processes, including accelerated approval, and FDA… more
- Rise Baking Company (Worcester, MA)
- …experience + 5+ years of management/supervisory experience + Proficient knowledge of regulatory disciplines (EPA, OSHA, FDA , USDA) + Strong employee and ... ensure employee and consumer safety, eliminate the variability affecting desired product quality , guarantee assets are maintained at base condition, and sustain 100%… more
- Nanobiosym, Inc. (Cambridge, MA)
- …fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. Minimum ... designing advanced PCB systems, driving embedded hardware development, and delivering high- quality products to market. This is a hands-on, technical leadership role… more