- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical leads, clinical pharmacologists, BST, discovery research scientists, regulatory , non-clinical and other functions to build consensus for ... PRC documents, CDP, clinical protocols, ICFs and documents submitted to Regulatory Agencies. + Support Business Development efforts by evaluating potential… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or ... regional regulatory agencies and be responsible for clinical pharmacology summary...desired minimum years industry experience: + Pharm D. or PhD with 8+ years of working experience in a… more
- Pfizer (Cambridge, MA)
- …at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD /JD with at least 5 years of experience or MD/DVM with at least 4 years of ... and Model Informed Drug Development. + Experience in global regulatory agency interactions. + Ability to apply pharmacokinetic and...over 12 years of experience or a Doctorate degree ( PhD /PharmD/JD) with 9+ years of experience, or a DVM… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …Prepares work areas for all inspections and participates in all internal, regulatory , safety and accreditation inspection processes as required by the Chief of ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
- Dana-Farber Cancer Institute (Boston, MA)
- …The DCNO drives adherence to standards of professional practice and regulatory requirements, ensuring compliance, and fostering a culture of evidence-based practice ... for high quality executive leadership in patient care and ensures regulatory compliance across the continuum. **Strategic Planning:** + Utilizes management… more
- AbbVie (Worcester, MA)
- …support to agency information request. Ensure all submissions comply with regulatory requirements and industry standard. + Collaborate with other analytical teams ... internal and external conferences and journals. Qualifications + MS or PhD in chemistry, biology, biochemistry, chemical engineering, or related technical… more
- Nanobiosym, Inc. (Cambridge, MA)
- …to support our research and communications team. The ideal candidate will have a PhD or Master's degree in a science discipline, and prior experience as a senior ... organizational objectives. + Translate technical research into accessible content for regulatory submissions, funding bodies, and public communication. + Review and… more
- Lilly (Boston, MA)
- …medicines for patients. **Position Overview:** We are seeking a highly skilled and motivated PhD level scientist to join our Diabetes team. This position will play a ... + Ensure all gene editing activities comply with relevant regulatory guidelines and standards. Maintain excellent scientific documentation, prepare reports,… more
- MAPFRE Insurance (Webster, MA)
- …forefront of transforming how we use data to make decisions. **What You'll Bring:** + PhD or Master's in a quantitative field + 8+ years in data science, Insurance ... monitoring, and retraining with a focus on fairness, explainability, and regulatory compliance. 7. **Expand AI Capabilities Through Partnerships** Collaborate with… more
- Nanobiosym, Inc. (Cambridge, MA)
- …matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions. + Dispute Resolution: Support IP litigation, opposition ... strategies. + Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA, EMA) as they relate to IP. more