Life Sciences and Drug Review SME - Senior ConsultantPennsylvania, Harrisburg, 17101 Harrisburg USA
OverviewGuidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies. For more information, please visit www.guidehouse.com. ResponsibilitiesGuidehouse has an exciting opportunity in our Public Health segment to support resource management for a major federal agency. The work will include performing an evaluation of how much demand is put on agency resources (personnel and systems), assessing if the resources are over-burdened or under-burdened, looking at how work is assigned and then performed, and identifying recommendations for a reallocation of resources. This position will help the client meet its critical mission-oriented need of protecting the public health. Guidehouse is looking for a candidate who can perform process improvement and data analytics to complete the required activities. Experience of five or more years is required. QualificationsRequired: The successful candidate has a record of working in the life sciences and/or drug review space and demonstrates the ability to learn quickly and think creatively. Specific skills and experience required include: Knowledge of the federal drug/device review and/or inspection process.
Familiarity with the FDA user fees
Familiarity with analytics, particularly forecasting and/or modelling.
Ability to develop strong team and client relationships
Excellent verbal and written communication skills (including presentation skills)
Creative problem-solving ability and a consultancy mindset
Experience developing and organizing information and data, preparing briefing charts, tables and graphs, and coordinating input from staff members.
Minimum of 5 years of relevant experience
Holds a four-year degree from an accredited college or university
Experience at the US FDA
Additional RequirementsThe successful candidate must not be subject to employment restrictions from a former employer (such as a non-compete) that would prevent the candidate from performing the job responsibilities as described.
This role can be based virtually from anywhere regionally in the following time zones: Eastern, Pacific and Central
DisclaimerAbout 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 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. 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. Rewards and Benefits 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
Position may be eligible for a discretionary variable incentive bonus
Parental Leave and Adoption Assistance
401(k) Retirement Plan
Basic Life & Supplemental Life
Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development & Learning Opportunities
Skills Development & Certifications
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Emergency Back-Up Childcare Program
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