Address
Form of workSUMMARY
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 provide professional support to the Senior Medical Officer for all of the regular activities of the IBTPP, including but not limited to, case discussions, research, meetings, etc. In addition, the Regulatory Physician will support the successful accomplishment of BabyBIG immunogen and BabyBIG next lot development activities. IBTPP is continuing its evaluation of an investigational botulinum vaccine for generating source plasma for BabyBIG production through an open-label clinical study, as was done for the prior lot of BabyBIG. The Regulatory Physician will have responsibility for working with the Senior Medical Officer to carry out the clinical study logistics and operations including, but not limited to, communications, data collection, data entry, and electronic and hard-copy file data management. The Regulatory Physician will participate in, and support as needed, all facets of BabyBIG vaccine and next lot development and will exercise discretion and independent judgment in doing so.
Applicants must submit a cover letter and curriculum vitae to be considered.
Must be able to work flexible hours, including weekends and holidays.
The salary range is $156,000-$185,000 depending on experience/qualifications.
If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date or have a valid religious or medical reason qualifying you for an exemption (that may or may not require an accommodation).
ESSENTIAL FUNCTIONS
Performs activities required for the production, distribution, and regulatory compliance of BabyBIG, including but not limited to, the preparation of regulatory submissions including BabyBIG safety reports, records maintenance related to the clinical study, case diagnostics confirmation information, and as needed regulatory requirements.
Prepares reports, spreadsheets and other documents to support regulatory compliance.
Advises clinical research and BabyBIG regulatory team on effective implementation of investigational botulinum vaccine clinical study logistics and immunogen and BabyBIG lot development activities. Examples include participant communications, obtaining medical history and performing physical examination of study participants, data collection, data entry quality, participant monitoring, and data management.
As directed, communicates and conducts interactions with federal agencies, state and local health departments, and program contractors about BabyBIG development activities
Performs other duties as required or assigned.
JOB QUALIFICATIONS
Education/Experience
Certificates/Licenses/Clearances
Preferred:
PHYSICAL DEMANDS
Not Applicable Not required for essential functions;
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 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.
https://recruiting2.ultipro.com/PUB1001PUBH/JobBoard/6705aa07-0bcb-4660-ad1b-2fda952becc7/OpportunityDetail?opportunityId=8c643c6c-c23f-49b4-8380-a52712449b71
EEOC STATEMENT
It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.
Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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 provide professional support to the Senior Medical Officer for all of the regular activities of the IBTPP, including but not limited to, case discussions, research, meetings, etc. In addition, the Regulatory Physician will support the successful accomplishment of BabyBIG immunogen and BabyBIG next lot development activities. IBTPP is continuing its evaluation of an investigational botulinum vaccine for generating source plasma for BabyBIG production through an open-label clinical study, as was done for the prior lot of BabyBIG. The Regulatory Physician will have responsibility for working with the Senior Medical Officer to carry out the clinical study logistics and operations including, but not limited to, communications, data collection, data entry, and electronic and hard-copy file data management. The Regulatory Physician will participate in, and support as needed, all facets of BabyBIG vaccine and next lot development and will exercise discretion and independent judgment in doing so.
Applicants must submit a cover letter and curriculum vitae to be considered.
Must be able to work flexible hours, including weekends and holidays.
The salary range is $156,000-$185,000 depending on experience/qualifications.
If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date or have a valid religious or medical reason qualifying you for an exemption (that may or may not require an accommodation).
ESSENTIAL FUNCTIONS
Performs activities required for the production, distribution, and regulatory compliance of BabyBIG, including but not limited to, the preparation of regulatory submissions including BabyBIG safety reports, records maintenance related to the clinical study, case diagnostics confirmation information, and as needed regulatory requirements.
Prepares reports, spreadsheets and other documents to support regulatory compliance.
Advises clinical research and BabyBIG regulatory team on effective implementation of investigational botulinum vaccine clinical study logistics and immunogen and BabyBIG lot development activities. Examples include participant communications, obtaining medical history and performing physical examination of study participants, data collection, data entry quality, participant monitoring, and data management.
As directed, communicates and conducts interactions with federal agencies, state and local health departments, and program contractors about BabyBIG development activities
Performs other duties as required or assigned.
JOB QUALIFICATIONS
- 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 Health Insurance Portability and Accountability Act (HIPAA) 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.
Education/Experience
- Medical school graduate
- Fluency with Microsoft software
- Excellent written and oral communication skills.
Certificates/Licenses/Clearances
- Medical school degree
- Active California medical license
Preferred:
- 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.
PHYSICAL DEMANDS
- 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 50 lbs.
- Push/Pull Occasionally - Up to 50 lbs.
- See Constantly
- Speak Frequently
- 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 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.
https://recruiting2.ultipro.com/PUB1001PUBH/JobBoard/6705aa07-0bcb-4660-ad1b-2fda952becc7/OpportunityDetail?opportunityId=8c643c6c-c23f-49b4-8380-a52712449b71
EEOC STATEMENT
It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.
Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
