The Assistant Director (AD) provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This support includes, but is not limited to, training and supervising regulatory staff, helping investigators develop regulatory strategies, analyzing changes in regulations for impact on CAGT protocols. The AD works closely with the Director to oversee all aspects of clinical research within for CAGT.
Actively works to maintain timely knowledge of federal regulations, institutional policies and ICH GCP guidelines in order to properly guide regulatory staff and investigators in preparing projects that are in compliance with those documents.
Helps to create SOPs that guide internal processes in order to facilitate compliance with federal regulations, institutional policies and ICH GCP guidelines.
Works with the regulatory staff and investigators in developing protocol documents and consent forms as necessary, works with regulatory staff and investigators to assist in responding to queries from institutional review committees and other regulatory agencies including the FDA.
Develops and maintains positive relationships with regulatory agencies, sponsors and other sites through oral and written communications.
Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
Helps to maintain systems meant to optimize communication of changes in regulatory processes to investigators, regulatory staff, and other involved parties.
Helps to maintain systems meant to optimize protocol specific information distribution to investigators, research staff, and other health care providers.
Three years in a regulatory affairs or compliance role.
Experience working with the FDA.
Five years in a regulatory affairs or compliance role.
Oncology, Cell or Gene Therapy experience.
Project Management experience.
Internal Number: 257285DP
About Baylor College of Medicine
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Please apply directly to vacancy #257285DP at www.bcm.edu/careers