Regulatory Project Specialist

Heluna Health•Richmond, CA

9d•Onsite

About The Position

The Infant Botulism Treatment and Prevention Program (IBTPP) is a unique public health/public service orphan drug program in the California Department of Public Health. IBTPP is the sole producer and distributor worldwide of the public service orphan drug that it created known as BabyBIG®. BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic disease of babies. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. The incumbent will support BabyBIG regulatory activities, provide professional response and service to callers requesting BabyBIG, and will carry out a variety of administrative support functions. IBTPP is seeking an individual with business experience who is interested in medical research, infectious diseases, and public health. The position reports to the Regulatory Manager and occasionally works with program technical staff. The ideal candidate will have business office experience that includes dealing with the public, preferably in medical, biotechnology, or laboratory environments or in pharmaceutical regulatory affairs. Candidates should have excellent communication skills, both written and spoken, and be able to effectively work in a sometimes fast-paced environment. Candidates should possess the qualities of professionalism, organization and punctuality.

Requirements

Exceptional communication skills, well-spoken and exhibit a professional demeanor
Possess business acumen and ability to professionally respond to concurrent requests
Comfortable with phone interactions, in-person communications, and electronic forms of communications; able to accurately relay information in a timely manner
Ability to follow detailed instructions, program protocols and policies
Well-organized and able to follow systematic methods of performing tasks
Ability to read and write English well, including spelling, grammar, and punctuation
Detail-oriented, with the ability to independently follow-through on tracking tasks and projects
Ability to handle medical and other sensitive information with discretion and confidentiality
Able to conform to standard business office practices and etiquette
Proactive and able to work with initiative and efficiency
Punctuality, tact, neatness, and excellent organizational skills
Bachelor’s degree in biological sciences, public health or pre-med curriculum preferred
Three years of business experience, including project management and fiscal tracking experience
Demonstrable customer service skills that include public interaction by phone
Prior office phone experience is essential, including handling concurrent callers
Skilled in computer applications including email, spreadsheet programs (Excel or similar), word processing (Word or similar), form editing or creation (Adobe or similar), familiarity with databases and internet browsers
Two years’ experience with data analysis and excel data models
Accurate management of physical and electronic files and medical documentation, including security and confidentiality awareness
Prior work in a medical/scientific environment; working with pharmaceutical products, or regulatory affairs preferred

Nice To Haves

Spanish or second language desirable

Responsibilities

Cross train on and master regulatory tasks related to BabyBIG requests tied to distribution, infant botulism epidemiology, and laboratory support needs
Coordinate BabyBIG-related activities like shipment, materials, and follow-up with vendors; maintain documents and related fiscal record-keeping
Assist with regulatory document operations related to BabyBIG development, manufacture, and distribution, such as complying with Standard Operating Procedures (SOP) and support maintaining up to date documents for vendor qualifications such as current confidential disclosure agreements and quality agreements
Assist with vendor management activities including support for performance of regulatory contracts, BabyBIG distribution incident resolution, procuring subcontracting services, vetting invoices, and projecting program budget needs related to maintaining a supply of BabyBIG
Facilitate monthly meetings with BabyBIG shipping and logistics vendors to support continuous quality improvement for BabyBIG shipments and their expedited delivery to ordering hospitals
Meet regulatory deliverables tied to BabyBIG inventory tracking and reporting workflows
Provide support for program modernization activities such as digitization, maintaining Electronic Document Management System (EDMS), and data analytics and governance
If or as assigned, coordinate regulatory-related program activities in support of the BabyBIG project