- Takeda Pharmaceuticals (Boston, MA)
- …with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. ... execution and interpretation of experiments in compliance with appropriate global regulatory guidance. + Effective and independent management of both internal and… more
- Takeda Pharmaceuticals (Boston, MA)
- …structured and unstructured datasets from clinical trials, real-world evidence (RWE), and regulatory databases (eg, FDA ), utilizing SQL and performing version ... analytics, generating actionable insights to address complex business problems in drug development and market access; translate unstructured business problems into… more
- Takeda Pharmaceuticals (Boston, MA)
- …support data-driven decisions in clinical development + Participate in preparation of regulatory submissions and responses to regulatory agencies. + Contribute ... functions **Core Skill and Qualification Elements:** + Advanced knowledge of drug development, clinical study designs, trial simulations, analysis methodology and… more
- Cardinal Health (Boston, MA)
- …with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Charles River Laboratories (Cambridge, 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
- Charles River Laboratories (Wilmington, 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
- Cardinal Health (Boston, MA)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Catalent Pharma Solutions (Chelsea, MA)
- …testing is conducted in line with the appropriate expectations, guidelines and/or regulatory test standards. **This is a full-time on-site salaried position: Monday ... and internal sources (ie health authorities, clients, self-inspections) + Understands regulatory requirements and their application as suitably scoped to support… more
- Cytel (Cambridge, MA)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… more
- AbbVie (Worcester, MA)
- …regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable. ... the qualification and validation of analytical methods in accordance with ICH, FDA , and USP guidelines, ensuring methods are suitable for late-phase development and… more
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