1. CAROL SHOLIN
510.303.9271 | tecolata@hotmail.com | https://www.linkedin.com/in/carolsholin
PROFILE
Organized, efficient, and self-directed Quality Assurance and Medical Writing/Editing
Professional offering a wide range of experience in quality and compliance systems in both large and
small bio-tech companies including start-ups and established businesses. Initiated process
improvements that streamlined and standardized tasks. Proven ability to work successfully in varied
environments.
TECHNICAL SKILLS
QUALITY ASSURANCE MEDICAL WRITING
 Change Control/Document Control  Protocols
 Discrepancy Management  Clinical Study Reports
 Technical Writing  FDA Submissions
 Batch Record Review  Clinical Development
 Internal Audit  Proofreading
 SOP  SOP
CAREER HIGHLIGHTS
• Prepared Trial Master File documents from initial draft through regulatory submission
including successful completion of 2014 cobas®
6800/8800 Blood Screening submission,
largest ever submission in FDA history.
• Implemented electronic document systems to streamline document review and approval
process.
• Created a template for Genentech Stability SOPs, which resulted in consistent, easy to use
format applicable for all commercial products stability testing.
PROFESSIONAL EXPERIENCE
ROCHE MOLECULAR SYSTEMS, INC., Pleasanton, California 2014 - present
Medical Writer
• Lead writing/editing teams, ensuring compliance with documentation quality standards and
regulatory requirements, and consistency across all documents for a product.
• Prepare regulatory documents for on-time submission to regulatory authorities.
• Facilitate on-time delivery of FDA filings in collaboration with content owners and life cycle
teams.
• Support clinical research studies leading to development of products and processes.
• Represent Medical Writing in cross-functional teams.
• Draft new/revised Standard Operating Procedures and sponsored change control process.
• Control electronic document management and electronic signature process.

2. • Resource for problem-solving with MS Word usage and formatting.

3. CAROL SHOLIN PAGE 2
GENENTECH, South San Francisco, California 2006 - 2014
Technical Writer/Editor II, Change Controller
• Created, edited, and formatted new Standard Operating Procedures and Test Procedures.
• Improved document drafting process by creating document templates, which resulted in
uniformity and simplification of departmental procedures.
• Identified and implemented process improvements.
• Reviewed corrective and preventive action (CAPA) to resolve and close discrepancies;
maintained CAPA metrics.
• Ensured GMP compliance by verifying approved changes captured in document revisions, and
that document changes complied with company procedures.
• Enabled Lot Release through quality review of Lot Release requests.
• Guided document changes through approval process from initiation to release.
BRIDGE PHARMACEUTICALS, Menlo Park, California 2005 - 2006
Medical Writer
• Wrote and edited Investigational New Drug applications (IND) for submission to US FDA.
• Reviewed documents for clarity, flow, consistency, organization, readability, and compliance;
drafted and edited standard operating procedures (SOPs) and company manuals.
• Developed templates for INDs, Pre-INDs, and SOPs.
• Trained in MS Word and Windows.
PENTA BIOTECH, Union City, California 1999 - 2004
Quality Associate
• Led start-up to GMP compliance including successful FDA Pre-Approval Inspection (PAI).
• Established GMP quality assurance program and performed all quality and safety activities
including discrepancy analysis, supplier quality, validation, calibration, and preventive
maintenance while serving as both technical writer and safety officer.
• Performed internal audits to verify compliance with company SOPs and with GMP, and to
identify potential training issues.
EDUCATION
Bachelor of Science - Biology major, Chemistry minor
University of Washington, Seattle