Regulatory Project Specialist

Job description 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. Additional program information may be found at: 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. The hourly pay range for this role is $30•38 depending on experience.

ESSENTIAL FUNCTIONS

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

JOB QUALIFICATIONS

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

EDUCATION/EXPERIENCE REQUIREMENTS

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 Spanish or second language desirable

PHYSICAL DEMANDS

Stand Occasionally Walk Occasionally Sit Frequently-Constantly Handling / Fingering Frequently-Constantly 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 Speak Constantly Taste/ Smell Not Applicable 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. The IBTPP is located at the CDPH Richmond Laboratory Campus on Marina Bay Parkway, Richmond, CA

ADDITIONAL INFORMATION

This position may require travel within the state of California in order to confer with CDPH staff, vendors, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.

APPLICATION PROCEDURE REQUIRED

for consideration: All applicants must upload both a cover letter and a resume to the recruiting portal. Via Employer Recruitment Website. PHFE dba Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled individuals to apply.

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. Keywords public-health environment-health-and-safety-hsse state-local-municipal external-workforce medical-facilities-services carried-interest health-foundations-medical-research biotechnology ecology-environment clubs-organizations salary-range warehousing-and-distribution distribution-and-storage epidemiology cabinet-construction-materials-hardware recordkeeping maintenance-repair-and-operations-mro training-and-development standard-operating-procedure-sop same-origin-policy-sop reporting-and-disclosure vendor-management supplier-management invoicing logistics-and-procurement adaptive-project-management-and-reporting provide-support digitalization electronic-document digital-document-management document-control document-storage content-document-management document-management-systems-dms digital-document-software-system-solution analytics data-analytics e-forms relays policies-and-practices education-training biological-sciences project-management word-processor web-browsers testing-and-analysis lift-and-shift non-disclosure-agreement-nda certificate-authority-ca cover-letters recruiting-career-management