- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and ... Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses… more
- Integra LifeSciences (Braintree, MA)
- …with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of ... resources, planning to meet goals and deadlines + This role ensures compliance within the document management system, document storage, retention, and document… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …drive a MIDD path within each At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To ... and external partners. + Maintains a high standard for good clinical practice, compliance , and ethics. + Mentors junior staff to promote scientific excellence and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... new or revised regulatory policies and initiate activities to support compliance + Participate in special projects and process improvement initiatives Qualifications… more
- Mentor Technical Group (Boston, MA)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering… more
- Sumitomo Pharma (Cambridge, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional… more
- ThermoFisher Scientific (Plainville, MA)
- …unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo ... operations. The manager collaborates closely with GMP and Operations to uphold compliance and product integrity. **Key Responsibilities:** Lead a team of quality… more
- Takeda Pharmaceuticals (Boston, MA)
- …(SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and review ... SDTM and ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide); contribute to process improvement initiatives for creating… more
- Charles River Laboratories (Wilmington, MA)
- …customer training, and product validations. * Responsible for completing all service and compliance documentation as required by company policy, cGMP and FDA . * ... our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... development and sustaining/remediation projects. + Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements. + Identify and… more