- 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
- Teleflex (Chelmsford, MA)
- …the site's Quality Management System (QMS) remains compliant with global quality and regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, ... and execution of strategies to ensure compliance with quality and regulatory standards, while delivering products, services, and processes that meet customer… more
- Cytel (Boston, MA)
- …satisfaction objectives. + Build and maintain relationships with senior stakeholders, including regulatory agencies (eg, FDA , EMA), key opinion leaders, and ... Demonstrated leadership in MIDD, Pop-PK/PK-PD modeling, and quantitative strategy within drug development. + Experience interacting with regulatory authorities… more
- 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
- Pfizer (Cambridge, MA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Takeda Pharmaceuticals (Boston, MA)
- …and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine ... collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. **Accountabilities:** **A Senior… more
- Charles River Laboratories (Shrewsbury, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... 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… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …biotech, or healthcare industry. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of… more