ELIQUENT Life Sciences · 1 day ago
Consultant (Non-Clinical)
United States
Contract
Remote
Senior Level, Lead/Staff
10+ years expELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. They are currently seeking a part-time Nonclinical Principal Consultant who is a subject matter expert in Toxicology/Pharmaceutical programs for small molecule drugs.
ConsultingMedical DeviceProfessional Services
Responsibilities
Demonstrate a strong scientific understanding of nonclinical drug development programs and design phase-appropriate nonclinical programs
Organize and present scientific methodologies, data analyses, and conclusions effectively in written form
Lead or participate in project meetings with clients and/or with regulatory authorities (e.g. US FDA) on their behalf
Exhibit high level of productivity in authoring or reviewing IND/BLA/NDA filing dossiers for clients under aggressive timelines with minimal supervision and guidance
Maintain solid and broad knowledge of ICH and FDA regulations related to overall drug development and be responsible for interpreting nonclinical guidelines and regulations
Conduct nonclinical gap assessments, program or study designs, and review study protocols and reports independently
Provide critical reviews of regulatory dossiers to ensure compliance with regulatory and scientific expectations and to meet stakeholder expectations, in addition to ensure accuracy and quality in written English
Train junior consultants through the creation of examples or templates, as well as through managing and critical review of their work product
Qualification
Required
Demonstrate a strong scientific understanding of nonclinical drug development programs and design phase-appropriate nonclinical programs
Organize and present scientific methodologies, data analyses, and conclusions effectively in written form
Lead or participate in project meetings with clients and/or with regulatory authorities (e.g. US FDA) on their behalf
Exhibit high level of productivity in authoring or reviewing IND/BLA/NDA filing dossiers for clients under aggressive timelines with minimal supervision and guidance
Maintain solid and broad knowledge of ICH and FDA regulations related to overall drug development and be responsible for interpreting nonclinical guidelines and regulations
Conduct nonclinical gap assessments, program or study designs, and review study protocols and reports independently
Provide critical reviews of regulatory dossiers to ensure compliance with regulatory and scientific expectations and to meet stakeholder expectations, in addition to ensure accuracy and quality in written English
Train junior consultants through the creation of examples or templates, as well as through managing and critical review of their work product
Excellent written and oral communication skills, with strong interpersonal skills to manage client and key stakeholder relationships
Proven ability to learn, understand, and master new subjects quickly
Capability to work effectively in a team-based environment
Project management experience required to coordinate the timely delivery of multiple projects
The candidate should be able to work independently and with minimal supervision
Preferred
Work experience in the regulatory agencies, such as the US FDA, in therapeutic areas of infectious diseases, autoimmunity, neuroscience, endocrinology, and nephrology is preferred
Experience with drug-device combination products or co-development of combinational drugs is highly valued
A broad familiarity with the drug development process, with a preference for candidates with 10+ years of relevant experience
Company
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
501-1000 employees
H1B Sponsorship
ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)
Funding
Current Stage
Late StageLeadership Team
Stephen Purtell
Chief Financial Officer
Rob Wojciechowski
Chief Operating Officer
Recent News
2025-05-08
globallegalchronicle.com
2025-04-07
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