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.

• 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 FDA
• Liaise 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.

• Bachelor's degree in a related field
• 5 or more year's experience in the medical device, pharmaceutical and/or regulatory field.
• Organizational and problem-solving skills
• Excellent interpersonal and communication skills.
• Ability to work positively in a team-orientated atmosphere and manage a fast paced work environment.
• Ability to successfully interact with diverse individuals, including investigators, nurses, participants and families, and industry and sponsor representatives
• Excellent computer skills

• 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)