Orphan Drug Regulatory Assistant

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 feesupported 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:

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 longterm interests are in medicine medical research public health or healthcare administration.

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 oncall physician schedules to ensure 24/7/365 coverage of programs consult line
• Liaise with afterhours phone service regarding oncall 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
• Crosstrain 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 skills and professional telephone manner
• Detailoriented with ability to followthrough on tasks and projects
• Exercises strict compliance to information privacy and data security standards
• Collaborative with use of good judgement to adequately escalate unusual scenarios that may arise
• Punctuality and promptness
• Ability to speak fluent Spanish is a plus (not required)

Education/Experience

• Prior office administration experience required approximately 12 years (parttime is acceptable) that includes general office functions and dealing with the public or outside liaisons by telephone preferably in a medical/scientific environment
• Recent university/college graduate: coursework in biological sciences premed public health or healthcare administration preferred
• Professional telephone experience required
• Proficiency with Microsoft Office applications especially Excel
• Document management experience preferred

Notes: This position requires coming to the CDPH/IBTPP office in Richmond CA which has free parking and is accessible by BART/shuttle. The work must be conducted during regular business hours of MF 8a.m5p.m.

APPLICATION PROCEDURE

Must upload both a cover letter and your resume with your name in the title of all documents. Your cover letter should state why youre interested in the position and how it will serve your studies or future goals. No phone calls please.

PHYSICAL DEMANDS

• Stand Frequently
• Walk Frequently
• Sit Frequently
• Handling / Fingering Frequently
• Speaking/Handling Phone Frequently
• Reach Outward Occasionally
• Reach Above Shoulder Occasionally
• Climb Crawl Kneel Bend Occasionally
• Lift / Carry Occasionally Up to 40 lbs
• Push/Pull Occasionally Up to 40 lbs
• See Constantly
• Taste/ Smell Not Applicable

KEY

• Not Applicable Not required for essential functions
• Occasionally 0 2 hrs/day)
• Frequently 2 5 hrs/day)
• Constantly 5 hrs/day)

WORK ENVIRONMENT

General Office Setting Indoors Temperature Controlled

EEOC STATEMENT

It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants without regard to age 40 and over) national origin or ancestry race color religion sex gender sexual orientation pregnancy or perceived pregnancy reproductive health decision making physical or mental disability medical condition (including cancer or a record or history of cancer) AIDS or HIV genetic information or characteristics veteran status or military service.