of contact and alliance manager for selected regulatory vendors, ensuring timely execution of regulatory submissions. Finalize submission...Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions...
Job Code 359057 Admin Dept/Program Admin Sub-Unit 057 Time Status Full-time Union 00 - Non Union... of ongoing clinical research studies to ensure protocol and regulatory compliance with Good Clinical Practices...
Trials Recruitment Innovation Center at Brigham and Women’s Hospital, the Clinical Trial Project Manager will oversee study... of underrepresented populations. The Clinical Trial Project Manager will maximize the utilization of existing recruitment methods...
Trials Recruitment Innovation Center at Brigham and Women’s Hospital, the Clinical Trial Project Manager will oversee study... of underrepresented populations. The Clinical Trial Project Manager will maximize the utilization of existing recruitment methods...
Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations... and Responsibilities: Develops content and format for regulatory submissions, and related supplements and amendments. Advises Medicare...
Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations... and Responsibilities: Develops content and format for regulatory submissions, and related supplements and amendments. Advises Medicare...
of regulatory activities and reporting associated with research studies; IRB submissions and renewals; and assisting... for a portfolio of projects focused on nutrition security, cardiometabolic disease prevention, and health equity. The Program Manager...
of regulatory activities and reporting associated with research studies; IRB submissions and renewals; and assisting... for a portfolio of projects focused on nutrition security, cardiometabolic disease prevention, and health equity. The Program Manager...
submission activities and be responsible for organization of CMC-related documents for regulatory submissions. Actively... Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC organization...
submissions and maintenance of regulatory files The above statements in this job description are intended to depict the general... of the Lead CRC, Senior Research Manager and Principal Investigator for assigned research studies, the Clinical Research...
evidence on the validity of COA endpoints and produce COA evidence dossiers for regulatory submissions. Prepares... study reports, and regulatory labelling interactions. You will also provide technical expertise and guidance...
Solving Skills, Regulatory Compliance, Reports Writing, Team Management, Technical Skills, Time Management Skills, Toxicology..., on-time reporting. Contribute to scientific and technical support for identification, development, qualification...
with the department’s program manager to help enhance the visibility of department investigators, both internally... transport/pick up from clinical areas and collaborating laboratories. On site work rather than remote work is a critical part...
with the department’s program manager to help enhance the visibility of department investigators, both internally... transport/pick up from clinical areas and collaborating laboratories. On site work rather than remote work is a critical part...
protocol submissions, response to review and continuing reviews. · Ensure compliance with MGH, IRB, NIH, FDA regulatory...-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions. These...
protocol submissions, response to review and continuing reviews. · Ensure compliance with MGH, IRB, NIH, FDA regulatory...-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions. These...
to ensure compliance to company quality standards and global regulatory requirements. The Principal Archivist contributes... and global Good Laboratory Practice (GLP) regulations [e.g., 21 CFR Part 58; OECD (Organization for Economic Co-operation...