- Merck (Boston, MA)
- …Provide final regulatory review and approval of: + Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local ... registration study protocols for secondary markets + Represent Global Regulatory...content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory… more
- Sumitomo Pharma (Boston, MA)
- …and healthcare compliance guidance in all activities, including those related to clinical trials , scientific interactions with internal and external groups, and ... strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Provide detailed and compliant… more
- Beth Israel Lahey Health (Boston, MA)
- …difference in people's lives.** This position is responsible in consultation with the Clinical Trials Office (CTO) Manager for providing an independent review, ... execution of the various contracts with industry sponsors for studies related to human subject research . Assess...sponsors for studies related to human subject research . Assess each contract for compliance with institutional policy… more
- Xybion Corporation (Boston, MA)
- …toxicologits, pathologists, non- clinical IT teams, CDO/CIOs for end to end trial management, protocol management, study data creation, reporting and SEND ... Sales Executive with significant experience in software and services sales for non- clinical functions. In this role you'll generate revenue opportunities with new… more