in support of clinical regulatory requirements. Ongoing Standards Compliance Stays current with all evolving regulatory... among direct reports. Collaborate with the Senior Director, Quality Assurance and Regulatory Compliance, and other members of the...
of complex business models. Ensure comprehensive clinical, financial, legal/regulatory, operational and other risk-related... in optimizing clinical operations and improving patient care outcomes, with knowledge of regulatory requirements and quality...
Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the... global project team and internal partners such as clinical operations, translational medicine, regulatory affairs...
Job Title: Director, Clinical Pharmacology & Pharmacometrics Job Location: United States Job Location Type: Remote.... General Description The Director, Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing...
? This Clinical Research Director (CRD) role in Early Neuro-Development is for a clinical expert of Alzheimer’s disease... clinical trials, analyzing trial data, interacting with regulatory agencies, and participating in internal decision making. CRD...
Job Title: Director, Clinical Operations Job Location: United States Job Location Type: Remote Job Contract... Type: Full-time Job Seniority Level: Director The Director, Clinical Operations Study Management is an operational and drug...
Job Title: Clinical Research Director Location: Cambridge, MA About the Job Are you ready to shape the future.... Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD) is noted as the...
Job Title: Clinical Research Director Location: Cambridge, MA About the Job Are you ready to shape the future.... Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD) is noted as the...
Job Title: Clinical Research Director Location: Cambridge, MA About the Job Are you ready to shape the future.... Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD) is noted as the...
, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents. Advanced leadership skills... scientific, technical and clinical expertise in respiratory/immunology field Has a demonstrated track record in clinical...
Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs. The role requires a well... in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures...
of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual... and objectives for the CTTD team that align with the company's overall strategy. Ensure compliance with regulatory guidelines: The...
of project team goals in compliance with applicable GCP/ICH guidelines and other regulatory requirements. The (Senior) Clinical... Senior Director of Clinical Operations or above. Plan, initiate and execute clinical studies while adhering to budget...
to ensure completion of project team goals in compliance with applicable GCP/ICH guidelines and other regulatory requirements...). This position will report to the Senior Director of Clinical Operations or above. Plan, initiate and execute clinical studies...
ensuring compliance with GVP regulations. Partner and support EAs in ensuring conduct of non-interventional, observational..., and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology...
regulatory requirements (e.g., FDA, IRB approvals, and liability management). Oversee compliance with all applicable laws..., regulatory compliance, corporate governance, and IPO preparation. Strong track record in drafting, negotiating...
Director Quality Assurance GCP's responsibilities will be: Provide expertise in GCP, GVP, and GLP compliance, offering...Senior Director Quality Assurance GCP - Permanent - Cambridge, MA Proclinical is seeking a dedicated professional...
preferred Excellent presentation and communication skills Knowledge of regulatory and compliance requirements related...Director, Global Scientific Training & Development, Medical Affairs Who we are: is a biopharmaceutical company...
, Regulatory and other medical functions. Must achieve and maintain compliance with all applicable Sanofi Specialty Care... regulatory, legal, and operational rules and procedures. About You Basic Qualifications Experience: clinical experience...
Director, Ex-US Health Economics and Outcomes Research (HEOR) Who we are: is a biopharmaceutical company... in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active...