1. Suzette L. Meredith
Oakland, CA 94619 • 510-534-9169(h) • 510-305-6798(c) suzzlorr@yahoo.com
QUALIFICATIONS Highly organized team leader and project manager. Extensive background in
pharmaceutical, legal and business industries; analytical, energetic, skilled
communicator with the ability to effectively multi-task.
PROFESSIONAL EXPERIENCE
9/10 – present Zogenix, Emeryville, CA
Quality Assurance Associate (contractor: 9/10 - 8/12; Employee: 9/12 - present)
• Receive daily product complaints (PCs) from call center; create files and verify completeness of
information; log information
• Prepare and send return kits (lab request form and cover letter) for problematic units to patients
• Create and submit Engineering Exam forms for returned units and submit to Engineering for
examination
• Reconcile monthly summary of PC reports from call center with in-house PC log
• Reconcile weekly PC Adverse Event Reports from Drug Safety with PC log and ensure Drug
Safety confirmation of receipt of same
• Correspond and follow up regularly with call center regarding incomplete product complaints
• Perform monthly and quarterly maintenance of GMP storage room
• Reconcile and log monthly lab invoices
• Review and sign off on Standard Operating Procedures (SOPs)
2/10 – 6/10 SuperGen, Inc., Dublin, CA
Patent & Contract Administrator (Contractor)
• Assisted in preparation/finalization of patent applications for filing with PTO
• Linked documents into patent database (Pattsy)
• Generated correspondence re status of contracts to in-house and third parties
• Maintained contracts docket: data entry, tracking and life cycle management
11/98 – 2/09 Facet Biotech (formerly PDL BioPharma, Inc.), Redwood City, CA
Regulatory Operations Associate, Regulatory Affairs (5/06 – 2/09)
• Prepared and assembled content for marketed drug product submissions to the FDA by
formatting documents, proofing, ensuring quality, accuracy and proper format according to
regulations
• Consistently and timely tracked and managed submission timelines and due dates for
responses to FDA requests
• Scanned and distributed documents; indexed and archived filings
• Worked closely with team members ( associates, managers, directors, VPs) to gather
submission content and ensure complete and accurate information
• Maintained inventory logs for advertisement, promotional and general correspondence
submissions
• Attended weekly operations meetings, electronic filing demos, standard operating
procedure meetings
Senior Administrative Assistant, Regulatory Affairs (7/04 – 5/06)
• Arranged videoconferences and Webcasts for educational training sessions
• Attended clinical/regulatory bi-monthly meetings to record, prepare and distribute action
items to attendees
• Processed and tracked Drug Safety SAE (serious adverse events) medical monitor review
requests
• Scheduled and coordinated in-house and off-site meetings, including arrangements for
travel, catered meals, hotel accommodations, and outside dining arrangements;

2. • Scheduled over 75 regulatory department interviews (including travel arrangements);
• Managed department VP’s calendar; processed monthly employee timesheets and
expense reports
Senior Administrative Assistant, Corporate Legal Department (11/98 – 6/04)
• Assisted Sr. V.P., General Counsel and corporate attorneys in due diligence compliances
for company offerings and potential mergers
• Heavy interfacing with senior management, board members and outside attorneys
• Drafted and finalized company corporate minutes and maintained corporate minute books
• Compiled information for drafting and finalizing SEC forms on behalf of officers/directors for
electronic filing (Edgar filing software) with the SEC
• Compiled documents and spreadsheets for legal department monthly audit reports for
finance department
• Drafted year-end audit representation letters to outside counsel for company audits and
annual company filings (10-K, 10-Q, etc.)
• Executed special or continuous research and data analysis tasks (e.g., extracted vital
information from 10b5-1 stock option plans, compiled information to file corporate forms
with State of California, redlining software, draft SEC Form 4s)
• Coordinated activities between internal departments and third parties
10/95-10/98 Aiken, Kramer & Cummings, Inc., Oakland, CA
Legal Secretary, Civil/Real estate Litigation; Business
• Drafted and finalized pleadings, appellate briefs and client letters
• Maintained calendars and indexed pleadings
• Compiled information for daily attorney work report for major clients
• Prepared agreements and leases for real estate transactions
• Created and maintained lease files
• Provided administrative support to office supervisor and staff
EDUCATION University of California, Berkeley, B.A. Psychology
University Honor Society
Biotech GMP/GCP course completion March 2006, June 2008
SKILLS Languages: Spanish (5 years), French (1 year)
Microsoft Office (WORD, Excel)
Edgar filing system software (SEC filings)
SAP - financial reporting module
Microsoft Outlook Calendar, Excel, Word 2007, Windows 7
Corel WordPerfect for Windows 95
Laserfiche, IKON scanners
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