Regulatory Operations Epidemiologist at Public Health Foundation Enterprises, In in Richmond, California

Job 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 Operations Epidemiologist (ROE). 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 IBTPP consists of a small team of 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

 Under the direction of the Regulatory Operations Epidemiologist Supervisor, the ROE provides programmatic regulatory capacity by assuring that effectiveness and utilization U.S. Food and Drug Administration (FDA) reporting requirements are met for BabyBIG activities. In close collaboration with epidemiological staff and supervisor, ROE manages IBTPP epidemiological operations relating to BabyBIG utilization and distribution and infant botulism case investigation and surveillance. This position has a very high degree of external representation for this specialized program that is highly visible within and without the Department.  Incumbent additionally plans, conducts, and analyzes epidemiological studies of infant botulism and related illnesses, e.g. Sudden Infant Death Syndrome (SIDS) and crib death and uses specialized software to describe and analyze the epidemiology of infant botulism. ROE assists with maintenance and development of IBTPP databases as needed. Incumbent uses a high degree of innovation, creative thinking, and independent planning to complete work.

All applicants must complete the application, and upload both a cover letter and a resume through the recruiting portal for consideration. 

Salary range: $80,000-$85,000 (depending on experience and qualifications) 

ESSENTIAL FUNCTIONS

• Maintain BabyBIG distribution and infant botulism surveillance database in Microsoft Access. Use Microsoft Access queries and other functions to create regular surveillance reports and other ad hoc reports as requested


• Perform and maintain regulatory epidemiological record-keeping for all BabyBIG treated and non-treated referrals and cases according to all current Standard Operating Procedures (SOPs)


• Collect surveillance data on infant botulism from physicians, state and local health department employees, health department microbiologists, and parents of patients


• Conduct epidemiologic interviews by telephone with parents of patients with laboratory-confirmed infant botulism in California and nationwide


• Provide guidance to Regulatory Operations Epidemiological Assistant in record-keeping, surveillance, case investigation, and regulatory duties


• Follow-up and accurate reporting and record-keeping of infant botulism clinical mimic patients


• Collaborate with BabyBIG regulatory team with pharmacovigilance activities by requesting medical records and assisting with data capture and reporting


• Analyze the epidemiology of infant botulism cases in California and throughout the United States using GIS (ArcGIS Pro) and statistical analysis software (SAS or R)


• Produce and contribute to reports and manuscripts for publication in peer-reviewed journals and review current scientific literature to maintain professional expertise and information about infant botulism and case studies


• Evaluate, analyze, recommend, implement and direct change-control measures for relevant databases and procedures for the epidemiological functions of the position and support staff


• Maintain accuracy and utility of site content on the Program’s public Web page


• Other duties as assigned (5%)

JOB QUALIFICATIONS

• Must be able to perform each essential duty listed above satisfactorily and professionally


• Be able to understand and comply with federal regulations related to orphan drug BabyBIG


• Able to work independently to complete assigned work in a timely manner with only occasional or minimal supervision


• Understand and comply with current Standard Operating Procedures


• Ability to handle medical and sensitive information with absolute confidentiality


• Ability to exercise discretion and good judgment at all times


• Ability to speak fluently and write clearly; good telephone skills and manners

 Education/Experience

• MPH or master’s degree in relevant field


• 3-5 years of related experience and training

Other Skills, Knowledge, and Abilities

• Prior experience in infectious disease epidemiology or nursing/medical field highly desirable


• Experience with regulatory and compliance adherence also preferred

 

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


• 
  Taste/ Smell:                        Not Applicable

KEY

• 
  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.

 

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.

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)

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