eNewsletter Signup
Miles
Km80.5

Clinical Contracts and Outsourcing Manager

FibroGen, Inc.

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: San Francisco, CA Posted Date: 4/29/2013 Position Type: Full time Job Code: 12BSP158 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research

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

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
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS