Regulatory Food Safety Toxicology SME

Guidehouse Inc.; Silver Spring (MD); Sur place; USD 65 000 - 108 000; Plein temps

Avantages offerts par ce poste

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Parental Leave

Tuition Reimbursement

Employee Assistance Program

Transit and Parking Benefits

Résumé du poste

Guidehouse is seeking 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 includes safety assessments, reviewing NDIN submissions, literature reviews, dose–response analyses, and preparing memoranda and regulatory documents.

Requires a Ph.D.

Qualifications

• Ph.D. in Toxicology, Pharmacology or related field required.
• 0–2 years of relevant experience in toxicology.
• Experience in safety assessments and risk characterization.
• Literature reviews and evidence synthesis experience.
• Strong writing and communication skills; ability to work independently.
• Able to obtain/maintain federal public trust clearance.

Responsabilités

• Conduct safety assessments and risk characterization of dietary ingredients and supplements.
• Review and evaluate NDIN submissions for regulatory review.
• Perform literature reviews and evaluate data quality.
• Integrate information from multiple sources to support conclusions.
• Conduct dose–response analyses and apply toxicological methods.
• Prepare technical memoranda, reports, and regulatory documents.
• Develop data gaps analyses and annotated bibliographies.
• Support ingredient prioritization and safety review activities.
• Present findings to reviewers and technical staff.
• Complete required training
• Utilize FDA databases and toxicology tools

Connaissances

Analytical thinking

Scientific writing

Independent work

Communication skills

Public trust clearance

Formation

Ph.D. in Toxicology/Pharmacology or related field

Description du poste

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 [e-mail] . 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 [e-mail].