Drug Development SME
Drug Development SME
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$ 171000 - 285000
1 Vacancy
Job Description
Job Family:
IT Project Management (Digital)
Travel Required:
Clearance Required:
What You Will Do:
- To provide scientific and technical guidance to Applied Regulatory Science management leadership scientists and project teams.
- Help interpret clinical and pharmaceutical data and provide value added support to the regulatory teams.
- Supervise guide bioanalytical and pharmacokinetic scientist in Applied Regulatory Science division
- Support the acquisition of a Laboratory Information System (LIMS) and ensure the inclusion of quality assurance aspects and division workflows.
What You Will Need:
- Masters degree in biology pharmaceutical sciences or related discipline
- Extensive knowledge in preclinical & clinical development.
- Minimum of 10 years of Experience
- Solid hands-on experience in pharmacokinetics (small & large molecules) Pharmacokinetic/Pharmacodynamic modeling & Simulations bioanalysis drug metabolism translational medicine and drug delivery and formulation.
- Demonstrated track record in analyzing and interpreting complex scientific data.
- Broad knowledge and proven supervisory skills.
- Exceptional oral and written communication skills and ability to network and build consensus within a multi-disciplinary organization.
- Drug regulatory experience is desired particularly in regulatory science research.
What Would Be Nice To Have:
- Ph.D. degree in biology pharmaceutical sciences or related discipline
- 20 years of experience in regulatory agency and pharmaceutical industry.
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
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 EmployerProtected 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- or via email at . 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 @ or . 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 Guidehouses Ethics Hotline. If you want to check the validity of correspondence you have received please contact . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicants 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.
Employment Type
Part-Time
