Carolyn P. Smith
San Francisco,CA
Summary
Dedicated pharmaceutical professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
9
9
years of professional experience
Work History
Manager, Strategic Outsourcing
FibroGen, Inc
03.2023 - Current
- Work cross functionally with clinical development teams (clinical, DM, Biometrics, safety, regulatory, quality and legal) to define and review vendor contract proposals and budgets
- Draft and track status of clinical work orders, change orders, clinical trial agreements, amendments and confidentiality agreements according to the defined scope of work
- Negotiate budgets related to each of the contract types above
- Gather and confirm facts from FibroGen Clinical team and vendors necessary to initiate agreements
- Perform review of contracts and comments from outside parties
- Create Purchase Requisitions in SAP
Senior Clinical Contracts and Outsourcing Analyst
FibroGen, Inc
09.2020 - 03.2023
- Update the relevant parties regarding outstanding agreements and budgets, and provide weekly updates to clinical team
- Following approval by the applicable functional area representatives and CC&O lead, 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
Contracts Associate
Gritstone Oncology, Inc
11.2019 - 06.2020
- Draft and negotiate multiple contract types, primarily from templates, including Non-Disclosure Agreements, Master Service Agreements, Scopes of Work, and Change Orders
- Utilize playbooks to negotiate contracts
- Monitor and track a large volume of contracts from draft to final signatures using SpringCM, contract lifecycle management system
- Maintain and update contract management system for each assigned contract
- Ensure company-wide compliance contracting policy
- Act as liaison between business partners, in-house counsel, and third party vendors
- Facilitate contract execution
- Build and maintain relationships with internal business clients
- Communicate with internal business partners regarding contract needs, obligations, and revisions
- Exercise judgment within defined procedures and practices to determine appropriate action
- Provide back-up administrative support in Legal as needed
Paralegal
Proteus Digital Health
10.2017 - 11.2019
- Review, edit, negotiate and execute contracts including: NDAs, MSAs, SOWs, CTAs
- Maintain database of all executed contracts
- First point of contact for internal contract requests
- Responsible for educating employees on contract requirements and the company’s approval process
- Support General Counsel with ad hoc research, calendar management, expense reports
Coordinator
Acerta Pharma, LLC
12.2016 - 10.2017
- Performed a variety of administrative tasks including, but not limited to: coordinating the signing, filing, and tracking of legal contracts and documents
- Drafted, proofread, and finalized legal contracts and documents
- Developed, implemented, and maintained legal filing and tracking systems, ensuring maximum company privacy and protection of confidential information and IP rights
- Scheduled meetings, prepared PowerPoint presentations, set up/maintained relevant trackers, checked government websites and databases for critical information and updates on clinical trial collaborators, and created periodic reports of legal contracts and documents needing review for renewal, termination, or amendment.
Administrative Assistant
Symantec
07.2015 - 04.2016
- Provided administrative support to the Product Legal Support and Patent Teams
- Scheduled meetings for the team and some calendar management
- Assisted with expense reports and travel arrangements
- Oversaw execution of B2B contracts
- Prepared data for QBRs displaying team performance in relation to quarterly goals
- Uploaded contracts into the corporate records repository and SIAMS database for use by various groups throughout the organization
- Updated contract information including product codes to SIAMS database
Product Management Assistant
10.2014 - 06.2015
- Reconciled and recorded discrepancies in contract agreements between E
- Trade and fund families
- Filed and maintained legal contracts on a daily basis
- Used advanced Excel techniques (lookups, pivots, macros) to update weekly, monthly and quarterly ETF Reports for E
- Trade database
- First contact for ad hoc reporting and analysis for Lead Product Manager
- Formatted outlines of graphics that were later created into webpages.
Education
B.S - Nutritional Science, Business Administration
San Jose State University, C. Santa Cruz
Extension Paralegal Certificate Course Jan - undefined
Skills
- Strong MS Office, Adobe Acrobat, Box, Salesforce, SAP, SharePoint
- Supply Contract Negotiation
Timeline
Manager, Strategic Outsourcing
FibroGen, Inc
03.2023 - Current
Senior Clinical Contracts and Outsourcing Analyst
FibroGen, Inc
09.2020 - 03.2023
Contracts Associate
Gritstone Oncology, Inc
11.2019 - 06.2020
Paralegal
Proteus Digital Health
10.2017 - 11.2019
Coordinator
Acerta Pharma, LLC
12.2016 - 10.2017
Administrative Assistant
Symantec
07.2015 - 04.2016
Product Management Assistant
10.2014 - 06.2015
B.S - Nutritional Science, Business Administration
San Jose State University, C. Santa Cruz
Extension Paralegal Certificate Course Jan - undefined
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