Regulatory Food Safety Toxicology SME

Guidehouse
  • Silver Spring, Maryland
    13 days ago

    Job Description

    Job Family:

    Scientist


    Travel Required:

    Up to 10%


    Clearance Required:

    Ability to Obtain Public Trust

    Our federal client is responsible for protecting public health through the scientific evaluation and regulatory oversight of dietary supplements. Guidehouse is seeking experienced Toxicology Subject Matter Experts to conduct safety evaluations of dietary ingredients and dietary supplement products, perform risk assessments, evaluate scientific evidence, and prepare technically defensible reports supporting FDA regulatory review activities.

    What You Will Do:

    • Conduct safety assessments and risk characterization of dietary ingredients and dietary supplement products.
    • Review and evaluate New Dietary Ingredient Notification (NDIN) submissions.
    • Perform systematic literature reviews and evaluate scientific data quality.
    • Integrate information from multiple scientific sources to support evidence-based conclusions.
    • Conduct dose-response analyses and apply toxicological risk assessment methodologies.
    • Prepare technical memoranda, scientific reports, and regulatory review documents.
    • Develop data gap analyses and annotated bibliographies.
    • Support ingredient prioritization and safety review activities.
    • Utilize FDA databases, scientific literature repositories, and toxicological assessment tools.
    • Present scientific findings and recommendations to reviewers and technical specialists.
    • Complete all required corporate, client, safety, security, and laboratory training requirements.

    What You Will Need:

    • Ph.D. in Toxicology, Pharmacology or a related scientific disciplines.
    • Minimum ZERO- TWO (0-2) years of prior relevant experience
    • Demonstrated experience conducting toxicology-based safety assessments.
    • Experience performing risk characterization and hazard evaluations.
    • Experience conducting literature reviews and evidence synthesis.
    • Strong analytical, scientific writing, and communication skills.
    • Ability to work independently assess complex scientific data and prepare technical reports.
    • Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred

    What Would Be Nice To Have:

    • Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory laboratory programs.
    • Dietary supplement or food safety regulatory review (I.e. NDIN) experience.
    • Familiarity with FDA guidance documents and review processes.
    • Experience using systematic review methodologies.
    • Experience preparing regulatory science memoranda, regulatory science reports and policy-supporting analyses.

    The annual salary range for this position is $65,000.00-$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.


    What We Offer:

    Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

    Benefits include:

    • Medical, Rx, Dental & Vision Insurance

    • Personal and Family Sick Time & Company Paid Holidays

    • Parental Leave

    • 401(k) Retirement Plan

    • Group Term Life and Travel Assistance

    • Voluntary Life and AD&D Insurance

    • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

    • Transit and Parking Commuter Benefits

    • Short-Term & Long-Term Disability

    • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

    • Employee Referral Program

    • Corporate Sponsored Events & Community Outreach

    • Care.com annual membership

    • Employee Assistance Program

    • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

    • Position may be eligible for a discretionary variable incentive bonus

    About Guidehouse

    Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

    Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

    If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at

    RecruitingAccommodation@guidehouse.com

    . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

    All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or

    guidehouse@myworkday.com

    .  Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.  Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

    If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact

    recruiting@guidehouse.com

    . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

    Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

    Numbers & Facts

    LocationSilver Spring, Maryland

    Skills

    • Accidental Death and Dismemberment (AD&D)unmatched
    • Adjudicationunmatched
    • Analysis Skillsunmatched
    • Banking Servicesunmatched
    • Centers for Disease Control and Prevention (CDC)unmatched
    • Communication Skillsunmatched
    • Corporate Fundingunmatched
    • Data Analysisunmatched
    • Data Qualityunmatched
    • Dental Insuranceunmatched
    • Documentation Reviewunmatched
    • Employee Assistance Planunmatched
    • Establish Prioritiesunmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • Food Safetyunmatched
    • Gap Analysisunmatched
    • Insuranceunmatched
    • Legalunmatched
    • Onboardingunmatched
    • Pharmacologyunmatched
    • Policy Analysisunmatched
    • Prescription Drugsunmatched
    • Public Healthunmatched
    • Recruiting/Staffing Agencyunmatched
    • Regulationsunmatched
    • Regulatory Reportsunmatched
    • Reporting Skillsunmatched
    • Riskunmatched
    • Risk Analysisunmatched
    • Technical Supportunmatched
    • Toxicologyunmatched
    • Tuition Reimbursementunmatched
    • United States Department of Agriculture (USDA)unmatched
    • United States Department of Defense (DoD)unmatched
    • Vision Planunmatched
    • Willing to Travelunmatched

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