- Norstella (Boston, MA)
- …life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is ... strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to… 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. + ... clients navigate the complexities at each step of the drug development life cycle -and get the right treatments...structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in… more
- J&J Family of Companies (Danvers, MA)
- …signal processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop ... test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. +...any other category protected under law. Abiomed maintains a drug -free workplace. Johnson & Johnson is an Equal Opportunity… 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
- Integra LifeSciences (Braintree, MA)
- …Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing ... Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED… more
- Takeda Pharmaceuticals (Lexington, MA)
- …role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic ... plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a...**Competencies:** + A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control… more
- Cardinal Health (Boston, MA)
- …GDPR (General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), ... maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key… more
- Editas Medicine (Cambridge, MA)
- …through nonclinical development including managing GLP and non-GLP studies, and regulatory submissions + Familiarity with FDA /EMA/ICH guidelines and proven ... models. The successful candidate will apply their knowledge, expertise and drug development experience to advance our gene editing pipeline. The responsibilities… more
- Charles River Laboratories (Wilmington, 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 ... service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues.… more
- Sanofi Group (Cambridge, MA)
- …strategy and the network of collaborators from preclinical research to operational, regulatory , and commercial functions. Success in this role requires the ability ... of responsibility. The GPH will be responsible for interaction with regulatory authorities, approval of protocols, informed consent documents, clinical study… more