- Sanofi Group (Cambridge, MA)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies,… more
- Cambrex High Point (Waltham, MA)
- …tests. + Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, ... a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug … 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 ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Biomat USA, Inc. (Worcester, MA)
- …and compliance with all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety ... activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a… 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 ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Abbott (Burlington, MA)
- …improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Sumitomo Pharma (Boston, MA)
- …Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard ... Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product...Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Charles River Laboratories (Shrewsbury, MA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... None. Other: Demonstrated analytical and problem solving capabilities. Understanding of regulatory requirements of study types assigned, as well as Testing Facility… more
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