Regulatory Physician
Heluna Health
Date: 8 hours ago
City: Richmond, California
Salary:
$160,000
-
$185,000
per year
Contract type: Full time
Job Details
Description
SUMMARY
Heluna Health and the Infant Botulism Treatment and Prevention Program (IBTPP) of the California Department of Public Health (CDPH) invite applications for the position of Regulatory Physician. IBTPP is a unique public health/public service orphan drug program in the California Department of Public Health. IBTPP is the creator, sponsor, producer and distributor worldwide of the licensed public service (i.e., not-for-profit) orphan drug, BabyBIG. BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic, infectious illness. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. The IBTPP consists of a small team of dynamic, dedicated professionals who work on the diagnosis, treatment and prevention of infant botulism and related disorders. Additional program information may be found at: www.infantbotulism.org.
The Regulatory Physician will initiate, lead, direct, supervise, and administer the distribution and regulatory activities related to BabyBIG for the treatment of infant botulism, including technical review and approval of all regulatory affairs submissions to the BabyBIG Biologics License Application (BLA) and associated regulatory compliance activities; oversee and manage the clinical consultation for referrals to the IBTPP of suspected cases of infant botulism; oversee distribution of BabyBIG domestically and internationally; manage BabyBIG regulatory Standard Operating Procedures (SOPs); conduct biennial review of and updates to SOPs; manage BabyBIG pharmacovigilance; directly supervise at least 1-2 staff members; and carry out other duties as required.
Applicants MUST submit a cover letter and curriculum vitae to be considered. Please provide three professional references.
Must be able to work flexible hours, including weekends and holidays, as needed.
The salary is $160,000 - $185,000 depending on experience/qualifications.
Essential Functions
Performs activities required for the distribution and regulatory compliance of BabyBIG, including but not limited to, the preparation of regulatory submissions including BabyBIG safety reports, and as needed regulatory requirements.
Prepares reports, spreadsheets and other documents to support regulatory compliance.
As directed, communicates and conducts interactions with federal agencies, state and local health departments, and program contractors related to BabyBIG.
Job Qualifications
Performs other duties as required or assigned.
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 and out-of-state in order to confer with PHFE, CDPH staff, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.
APPLICATION PROCEDURE
REQUIRED for consideration: all applicants must complete the application, and upload both a cover letter and a curriculum vitae to the recruiting portal.
Via Employer Recruitment Website.
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.
Description
SUMMARY
Heluna Health and the Infant Botulism Treatment and Prevention Program (IBTPP) of the California Department of Public Health (CDPH) invite applications for the position of Regulatory Physician. IBTPP is a unique public health/public service orphan drug program in the California Department of Public Health. IBTPP is the creator, sponsor, producer and distributor worldwide of the licensed public service (i.e., not-for-profit) orphan drug, BabyBIG. BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic, infectious illness. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. The IBTPP consists of a small team of dynamic, dedicated professionals who work on the diagnosis, treatment and prevention of infant botulism and related disorders. Additional program information may be found at: www.infantbotulism.org.
The Regulatory Physician will initiate, lead, direct, supervise, and administer the distribution and regulatory activities related to BabyBIG for the treatment of infant botulism, including technical review and approval of all regulatory affairs submissions to the BabyBIG Biologics License Application (BLA) and associated regulatory compliance activities; oversee and manage the clinical consultation for referrals to the IBTPP of suspected cases of infant botulism; oversee distribution of BabyBIG domestically and internationally; manage BabyBIG regulatory Standard Operating Procedures (SOPs); conduct biennial review of and updates to SOPs; manage BabyBIG pharmacovigilance; directly supervise at least 1-2 staff members; and carry out other duties as required.
Applicants MUST submit a cover letter and curriculum vitae to be considered. Please provide three professional references.
Must be able to work flexible hours, including weekends and holidays, as needed.
The salary is $160,000 - $185,000 depending on experience/qualifications.
Essential Functions
Performs activities required for the distribution and regulatory compliance of BabyBIG, including but not limited to, the preparation of regulatory submissions including BabyBIG safety reports, and as needed regulatory requirements.
Prepares reports, spreadsheets and other documents to support regulatory compliance.
As directed, communicates and conducts interactions with federal agencies, state and local health departments, and program contractors related to BabyBIG.
Job Qualifications
Performs other duties as required or assigned.
- Doctor of Medicine degree
- Active California medical license
- High level analytical and problem-solving skills.
- Attention to detail.
- Demonstrated ability to effectively communicate orally and in writing with public health and healthcare professionals and internal partners.
- Knowledge and application of the Information Practices Act of California requirements and protection of health information.
- Ability to prioritize and manage multiple tasks and work independently.
- Demonstrate reliability and integrity.
- Fluency in spoken and written English.
- Medical school graduate
- Fluency with Microsoft software
- Excellent written and oral communication skills.
- Medical school degree
- Active California medical license
- Experience working with clinical databases
- Knowledge of botulinum toxin, infant botulism and its treatment
- Experience working in public health or other medical programs for at least two years
- Experience in clinical research, pharmaceutical product development, monitoring and regulatory affairs
- Board-eligible or Board-certified in pediatrics, internal medicine, or family practice.
- Stand Occasionally
- Walk Occasionally
- Sit Constantly
- Handling / Fingering Constantly
- Reach Outward Occasionally
- Reach Above Shoulder Occasionally
- Climb, Crawl, Kneel, Bend Occasionally
- Lift/Carry Occasionally Up to 25 lbs.
- Push/Pull Occasionally Up to 25 lbs.
- See Constantly
- Speak Frequently
- Taste/ Smell Not Applicable
- Occasionally (0 - 2 hrs./day)
- Frequently (2 - 5 hrs./day).
- Constantly (5+ hrs./day)
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 and out-of-state in order to confer with PHFE, CDPH staff, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.
APPLICATION PROCEDURE
REQUIRED for consideration: all applicants must complete the application, and upload both a cover letter and a curriculum vitae to the recruiting portal.
Via Employer Recruitment Website.
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.
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