Regulatory Project Specialist

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

• Bachelors 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

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.

Required Experience:

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