American Heart Association Quality Initiative, Target: Aortic Stenosis Project

Manage international medical congresses for our pipeline product, publications for our commercial product, grants and contributions, medical information requests and KOL collaboration.

Responsible for management/coordination of Medical Affairs operations for Omeros including developing relationships with key opinion leaders, drafting publication plan and oral presentations, posters and manuscripts, and responding to inquiries regarding clinical data.

Clinical Project Manager for Omeros' first commercial application (NDA/MAA). Developed drafts of Clinical Study Reports (CSRs) and coordinate the flow of documents from content owners to reviewers ensuring regulatory compliance for publishing.

Provide mission and fiduciary oversight.

Initiated and managed 6 cardiology studies and an endocrinology study at Overlake Hospital Medical Center and Overlake Internal Medicine Associates. Developed sponsor relationships, performed budget evaluations and assessed protocol suitability. Responsible for patient screening, consenting, enrollment, visit evaluations and data capture as well as maintenance of source documentation, drug accountability and regulatory compliance.Trained staff at hospital and clinic prior to launch of new research trial.Mentor/Supervisor of Clinical Research Assistant and Summer Interns.

Managed Group Health Cooperative (GHC) Account, increasing access and formulary adoption of Merck Products.Achieved superior performance, averaging 127% of expected sales.Awarded 'Vice President's Award' in 2000 for leadership and performance. Successfully forged relationships with management and staff to provide research data on Merck products within GHC's Evidence Based Medicine Guidelines.Proactively identified sales opportunities and designed tactical sales plan, aggressively driving sales activity at the regional level.Expanded role of medical liaison for cardiovascular, respiratory, dermatology, rheumatology and neurology departments.

Project Team Leader responsible for conducting internal and external audit activities for Antihypertensive (Cozaar and Hyzaar) and Migraine (Maxalt) Worldwide Marketing Applications. Provided quality assurance audit assistance to Infectious Disease/Protease Inhibitor team for the fast-track application of Crixivan. Verified data integrity against source documentation.Monitored sites for GCP compliance and data integrity, domestically and internationally.

Managed U.S. and International Phase 3 Clinical Trial in hypertensive patients. Developed protocol, documented study procedures, tracked patient recruitment and IRB approval documents.Trained clinical trial nurses and physicians on protocol and provided support for on-target enrollment.Monitored sites during Phase IIb and III, including site initiation visits, for data verification against source documentation and regulatory compliance. Coordinated and presented at U.S. and International Protocol Launch meetings.Instrumental in writings sections of Worldwide Marketing Application which resulted in the approval of Cozaar and Hyzaar by the FDA and other International agencies.