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Orphan Drug Regulatory Assistant
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Public Health Foundation Enterprises, In
Richmond, CA (In Person)
$49,920 Salary, Full-Time
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Job Description
The Infant Botulism Treatment and Prevention Program (IBTPP) is the developer and sole distributor of the orphan drug Botulism Immune Globulin Intravenous (Human) (BabyBIG®). BabyBIG is the only treatment available for the orphan (rare) disease known as infant botulism. The IBTPP is established as a fee-supported, special fund activity of the State of California. Our team consists of a small, dynamic group of professionals dedicated to improving the diagnosis, prevention and treatment of infant botulism and related disorders. Program information may be found at: www.infantbotulism.org The Orphan Drug Regulatory Assistant (ODRA) role contributes to the essential functions of IBTPP via office work to support our 24/7/365 consult line during business hours by fielding and directing requests from ordering hospitals, Hospitals labs, health departments, concerned family members, or other program inquiries. Additionally, ODRA will collect and organize primary medical records and referral documents pertaining to patients with infant botulism. In combination, these duties contribute to the creation of new knowledge and support ongoing research on infant botulism. The position within the IBTPP provides an opportunity for involvement with a multidisciplinary medical and public health research team addressing orphan drug development and distribution, molecular biology, microbiology, epidemiology, and regulatory (FDA) affairs. The ODRA contributes to regulatory and epidemiology aspects of the program and provides service both to external callers and program staff. We are seeking candidates whose long-term interests are in medicine, medical research public health, or healthcare administration. The pay rate for this role is $24.00 per hour.
ESSENTIAL FUNCTIONS
- Provide excellent, clear, and organized administrative support for IBTPP
- Facilitate referrals from medical providers treating patients with suspected infant botulism who request medical consultation
- Field and accurately direct telephone calls and email messages from physicians, public health departments, hospitals, consultants, contractors, vendors, patient families, and staff
- Adhere to standard procedures related to communications, document management, and regulatory compliance
- Reliably process regulatory documentation and data entry related to BabyBIG orders
- Coordinate on-call physician schedules to ensure 24/7/365 coverage of program's consult line
- Liaise with afterhours phone service regarding on-call schedule and transition of telephone line to after business hours
- Request and process patient medical records and itemized bills, as needed
- Support invoice processing workflows
- Cross-train and cover standard regulatory epidemiology workflows related to the provision of BabyBIG, as needed
- Other BabyBIG or related regulatory special projects as assigned
JOB QUALIFICATIONS
- Exceptional communication .