Our client has engaged us for a full-time permanent Nonclinical Consultant position. They are seeking a mid-level experienced scientific professional with a strong nonclinical study monitoring background to join their team of experienced professional toxicology consultants. Organization: A scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills.
Responsibilities:
•Manage all aspects of outsourced nonclinical studies including study design, competitive bidding, pre-study activities, study monitoring, data, and report review.
•Monitor the studies including site visits, as needed, to ensure scientific, regulatory, compliance, and animal welfare regulations expectations are met, and quality reports are delivered on an agreed-upon timeline.
•Provide technical and scientific nonclinical study advice for a wide range of study designs, routes of administration, and species commonly used in drug development.
•Provide regulatory toxicology support to clients.
•Author reports and/or regulatory documents as needed.
•Interact with clients and vendors.
•Provide scientific and innovative advice to internal and external parties.
•Participate in business development activities.
Knowledge and Skills:
•Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
•Prior experience in Study Directorship or coordination in a Contract Research Organization (CRO) is highly desired.
•A minimum of 4 years in the pharmaceutical/biotechnology industry, CRO, and/or consulting with significant study monitoring experience.
•Good understanding of technical study conduct, study design, procedures, and documentation practices and regulatory requirements.
•Proven knowledge of Good Laboratory Practices (GLP).
•Demonstrated organizational and project management skills.
•Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.).
•Ability to work independently and within a group setting and to interact effectively with different functional areas.
•Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
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Job Features
| Job Category | Nonclinical |
| Reference Number | 201054 |