Job Family:

IT Project Management (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:

• Collaborate with data management team.
• Support program reporting, develop statistical applications and summary reports that can be regularly delivered to management
• Work on data integration and reformatting requests.
• Processing raw data analysis, summarize studies and regulatory projects and innovations required for leadership decisions.
• Collaborate with data analyst for statistical analysis for data-driven reporting and proactive program management.
• Provide subject matter expertise and business analysis capabilities to enhance efficiencies during design thinking sessions and regulatory review processes for following business domains areas including but not limited to Clinical, Nonclinical, and Inspections and Compliance (specifically, BIMO modernization effort and SAS modernization program); including Data Standards and Management Support – Validation and Review of Nonclinical SEND Submissions from Industry sponsors

What You Will Need:

• Bachelor's or Master's degree in a relevant discipline or equivalent work experience.
• At least SIX (6) months of curating and managing data sets experience.

• Knowledgeable in preparing manuscripts and data for publication.
• Analyze program budgets, and schedules and generate risk analysis and mitigation strategies.
• Track record of managing a team's performance to achieve organizational goals and exceed client expectations.
• Experience working and collaborating with other leaders to pursue add-on and cross-business opportunities with current and prospective clients.
• Knowledge of Microsoft Office 365 platform.

What Would Be Nice To Have:

• Relevant professional certification(s) (e.g., Project Management Professional - PMP, Lean Six Sigma Green Belt, Certified Change Management Professional - CCMP)
• Excellent analytical, organizational, and time-management skills.
• Existing strong relationships with FDA and other HHS leaders
• Very beneficial to have worked with collaborators from different areas of expertise.
• Strong oral and written communication skills. 
• Conduct scientific analyses and assessments of drug products that are the subject of product-specific guidance development.
• Perform analyses and assessments on regulatory products– including clinical, non-clinical, and pharmacologic study reports.
• Conduct scientific analyses of the relevant factors that can impact in vitro and in vivo performance, such as variations in the properties of drug product formulation that control the amount and relative bioavailability of drug delivered and identify remaining knowledge gaps.
• Translate the results from current research into new bioequivalence methodologies and standards to provide alternative bioequivalence approaches, and facilitate the internal review process and approval of generic products.
• Support database and model development for predictive and risk assessments of physiochemical and pharmacokinetics (PK) properties.
• Support scientific communication, summary, and writing of new regulatory science advances to inform industry stakeholders in the forms of meeting presentations, posters, reports, and scientific publications.

The annual salary range for this position is $65,900.00-$98,900.00. 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 Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, 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 [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

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.