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Clinical Contracts & Outsourcing Manager (12-158) FibroGen
Description:This person will be a member of the Clinical Contracts and Outsourcing Team. This person will assist FibroGen team members in the drafting, negotiation and administration of non-disclosure, vendor services, and other agreements. This position will manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for execution by corporate officers and perform other duties as assigned by the FibroGen team members.
This position reports to the Associate Director, Clinical Contracts and Outsourcing.
Duties Include but are not limited to:
Draft, negotiate and track status of clinical work orders, change orders, amendments, bioanalytical and confidentiality agreements
Update the relevant parties regarding outstanding agreements and budgets, and provide weekly updates to clinical team
Process all agreements for execution, ensuring that the appropriate departments within FibroGen receives a copy
Gather and confirm facts necessary to initiate contract formation with FibroGen Clinical team
Perform initial review of contracts and comments from outside parties
Negotiation with outside parties
Prepare/format and finalize contracts for execution
Work with FibroGen Legal document-tracking database
Monitor contracts for compliance with company and department policies
Liaise with legal for review of contract language
Mentor Clinical Contract Associates
Establish, draft and train with respect to process documents
Job Requirements:
BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience a plus.
At least five (5) years of contract negotiation experience
Minimum of five (5) years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company
Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR)
Excellent negotiation and written/verbal communication skills
Ability to work independently, creative thinking and problem solving skills
Ability to understand the full clinical development process
Must understand the ?Sponsor of Choice? philosophy
Must have good organization and planning skills, proven ability to handle multiple priorities and work independently
Must be a team player and be a leader within the department
Proficiency with MS Word, Excel, Access and Outlook required
| Location: | San Francisco, CA United States |
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FibroGen
Investors: Bain Capital VenturesAll Jobs: at FibroGen
| Web Site: | www.fibrogen.com |
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| Headquarters: | 225 Gateway Boulevard South San Francisco, CA 94080 United States |
| Industry: | Biotechnology |
