OBJECTIVE

I am interested in contributing my skills to the healthcare industry. I have experience in many different disease states, oncology, rheumatology, ALS, Alzheimer’s and Parkinson’s. I enjoy working in a team environment.

SKILLS

I have well-developed project management, data management, analytical, organizational, and leadership skills. I am a thorough, flexible, organized, detail-oriented individual with the ability to motivate and influence others.

PC and Mac proficient

Well-versed in clinical product development from research to regulatory approval

Thorough eye for proof-reading and editing of a variety of document types

EXPERIENCE

Consultant Armagen January 2016-June 2016

Competitive analyses of clinical studies. Develop archive of hardcopy as well as electronic data. Create training slide decks and reference documents for safety programs within the lab.

Consultant Baxalta January 2016-March 2016

Review and edit labeling materials for Baxter to Baxalta changeover. Develop electronic repository for labeling. Coordinate development of draft pacritinib label with input from relative departments.

Consultant Baxter BioScience December 2010-January 2016

Competitive risk analysis of labels. Review of labeling and promotional items for products near approval. International liaison for CMC-related issues. Compile CMC annual report of changes for global manufacturing sites, streamlining process to a single coordinated database of reportable changes. Develop SharePoint site for “Best Practices” for regulatory meetings, discussions, and responses.

Self-employed Busy Bee Skincare June 2008-December 2013

Professional, licensed esthetician and owner/operator of Busy Bee Esthetics in Malibu, CA. Served over 300 clients in Malibu and the Conejo Valley. Responsible for all aspects of the business including creative writing for brochures, website and all marketing collateral materials. Created private label product line. Guest lecturer at West Valley Occupational Center for Cosmetology (April 2014).

Consultant Amgen Inc. May 2005 - June 2006

Consultant for Amgen's Regulatory Affairs Labeling Group. Responsible for development of multiple products in early clinical development as well as creating risk/benefit scenarios for future marketed products versus competitors from a labeling perspective.

Marketing Manager Amgen Inc. September 2002 - November 2003

Brand Planner for Amgen's Inflammation Business Unit responsible for the co-marketed billion-dollar product Enbrel with Wyeth Pharmaceuticals and Amgen's Kineret. Duties beyond general brand planning included managing advertising and promotion budgets over $200 million, as well as developing and implementing a new injection system to increase competitive advantage in the marketplace and focusing on opportunities in JRA. Managed multiple market research projects regarding injection system, instruction sets and general patient-focused research.

Sr. Sales Operations Analyst Amgen Inc. October 2000 - August 2002

Communications interface with various departments at Amgen to develop and distribute communications and messaging for Amgen Inc.'s U.S.-based Sales and Marketing staff. Project manager for various sales force-related activities. Responsible for developing SOPs and streamlining the interface between headquarters and the field. Writing, editing and launching multiple salesforce related communications daily.

Regulatory Affairs Roles Amgen Inc. September 1992 - October 2000

Interface with internal Amgen departments and FDA to develop and implement appropriate labeling/marketing materials for Amgen's billion-dollar oncology franchise. Develop and review products in clinical stages of development for future commercialization from a labeling and advertising/promotion perspective. Develop SOPs for review processes, as well as development and maintenance of databases for tracking labeling changes as and review of advertising and promotional materials. Responsible for multiple other Regulatory-related requirements such as state licensing and review and assessment of labeling and commercialization-related regulatory requirements. Manage the drafting of package inserts (prescription information) for products in development and life-cycle management. Track and maintain global package insert drafts and current in-print documents. Develop standard processes for development and review of prescription drug product inserts and responsible for drafting multiple patient information leaflets.

EDUCATION

Master in Business Administration Pepperdine University April 1998

Graduated Magna Cum Laude

Bachelor of Arts, Business and Foreign Language California Lutheran University May 1993

Graduated Magna Cum Laude; Student Assistant Honors, Foreign Language Department/Society Honors

State Board of California Esthetician License Z 79359 Simi Valley Adult School May 2008

Foreign Studies

International Relations Oxford University Spring 1990

Elise Averdick Gymnasium, Hamburg, Germany 1986-1987

REFERENCES

Douglas Hunt, Vice President, Armagen

805-***-****

Armine Balian, Senior Manager, Shire

818-***-****

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