Research Compliance Spec Sr

Job Summary: This position provides regulatory support, consultation, training and FDA liaison support to U-M clinicians requesting Expanded Access (EA) drugs and devices for their patients. This role requires working positively in a team-oriented atmosphere and managing a fast-paced work environment. The successful individual must be able to work independently and to interact with diverse individuals, including physicians, nurses, participants and families, and manufacturer representatives.

Responsibilities: Responsible for the management and oversight of expanded access approvals for investigational drugs, devices, or biologics. This includes the following duties: Prepare and submit single and multi-patient expanded access INDs and related submissions including responses to FDA inquiries, safety reports, and other life-cycle maintenance submissions to FDALiaise with manufacturers on behalf of UM physicians, both to obtain manufacturer approval for EA cases and to complete requirements for compassionate use to medical devices Assure regulatory compliance for EA submissions via Support for UM physicians and clinical teams to provide regulatory guidance and expertise Preparation of IRB documentation for EA cases including drugs, biologics, and medical devices, including applications, informed consent documents, and maintenance requirements Critical review of submission documents such as treatment protocols and informed consent documents to ensure compliance with regulatory requirements Contribute to patient care coordination by interacting with providers, clinical and regulatory stakeholders, and patients and families as required. Provide logistical and regulatory coordination for industry-sponsored multiple-patient expanded access programs, including maintenance of regulatory binders and related documentation, data entry, initiation of supply shipments, and patient enrollment Work collaboratively across departments to assure optimal care of EA patients Assist in providing regulatory education and training to physicians, clinical teams, and other research/regulatory/clinical personnel Demonstrate strong knowledge of the regulatory process and works toward process efficiency for all team members. Contribute to continuous quality improvement through identification of opportunities and implementation of solutions. Other duties as assigned.

Desired Qualifications: Understanding of the clinical research environment, as demonstrated by previous work in clinical trials/regulatory affairs and/or related certifications (CCRC, CCRP, RAC, etc.)2-5 years' experience in the regulatory field, specifically in the submission of IND's and IDE's, or experience with filing an NDA, BLA, PMA or 510(k)