Project Manager Management

Qualifications Profile

Accomplished professional experience in marketing, project management, and

regulatory affairs.

Excelled at driving project timelines & resources for preeminent

biotechnology and IT firms. Strong business acumen and sound judgment;

adept in building sustainable teams to improve new product approval in

European and US markets. Strong business development background creating

strategy, project plans, and teams for both entrepreneurial and large

corporations.

. Cost-conscious and innovative problem solver who implemented

regulatory procedures and improved management systems saving tens of

thousands of dollars.

. Skilled manager & team builder with experience generating efficient

processes and procedures.

. Clear communicator able to lead effectively across global divisions

and organizational levels.

Additional capabilities:

Regulatory Affairs Hiring, Training, Web 2.0 Development

Needs Assessment Evaluating Marketing Strategy

Strategic Planning Financial Management Global Communications

Relationship Building High-level Presentations Cross-functional

Collaboration

Project Management

Experience

Petrys Consulting, San Ramon, California . 2007 - Present

Business Consultant

Providing consulting services for small and start-up companies looking to

establish business plans, marketing plans, competitive analysis, product

planning, budgeting, contracts review, and operations.

. Launched successful Web 2.0 and traditional companies with budget

conscious clients

. Skilled presenter and negotiator for client or investor meetings

. Manage product deliverables, timelines, budgets, and quality metrics

Gilead Sciences, Foster City California . 2012-2013

Project Manager, Regulatory Affairs (contractor)

Responsible for the co-ordination, prioritization, and tracking of global

regulatory activities. Developed and maintained aggressive but achievable

detailed timelines with global team members ensuring timely submission to

regional health authorities. Tracked regulatory commitments such as follow-

up measures, PSUR, DSUR, annual reports, and post-marketing commitments.

. Managed sNDA and Type II variations for marketed HIV products

. Developed tracking and reporting tools for global regulatory

activities

. Liaised with global clinical, regulatory, labeling, medical writing,

and operations

Santen Inc, Emeryville, California . 2011

Specialist, Regulatory Affairs (contractor)

Managed the Clinical Trial Application (CTA) submissions for multinational

ophthalmic studies. Created timelines, identified required technical

documents, coordinated with departments for authoring, and oversaw project

deliverables. Established procedures to manage correspondence with health

authorities and answer questions. Authored clinical and regulatory

responses to questions regarding protocol, informed consent, and CMC

related issues.

. Established procedures and managed submissions ensuring regulatory

compliance

. Researched both FDA requirements and competitor summary basis of

approval for management

. Core team leader of rapid response team established to ensure adequate

and timely response to health authority questions

. Managed external contractor relationships from selection to execution

Novartis (Chiron), Emeryville, California . 2000 -2007

Manager, Regulatory Affairs (2004 - 2007)

Managed Regulatory Operations team supporting agency correspondence and

submissions. Improved processes and procedures for assembly of dossiers for

submission. Created workflows, coordinated departmental approvals for

submissions, and established timelines. Coordinated activities regulatory

personnel and document authors with project timeline. Selected and managed

teams to meet submissions requirements. Oversaw direct reports and managed

$500K budget.

. Established advanced FDA submission methods, replacing paper with

electronic submissions, improving efficiency and resulting in hundreds

of thousands of dollars in cost savings

. Contributed to cross-functional collaboration, more closely

integrating Regulatory Affairs with other divisions

. Created long-term strategy to integrate global regulatory system

Project Manager (2000 - 2004)

Liaison among several divisions and IT department. Proposed and documented

business units' business requirements, including: Environmental Health and

Safety, Business Development, Legal, and Travel, coordinating and aiding in

definition of departments' technology requirements and IT needs. Oversaw

projects to upgrade technologies, such as establishing central database.

. Improved data quality, managing projects to make information more

available for Environmental Health and Safety division

. Managed strategy, mapping, and implementation of software for global

regulatory operations

Ibycus Consulting, Inc., Oakland, CA . 1998 - 2000

DIRECTOR OF OPERATIONS

Developed and managed processes for consulting firm to startup e-commerce

companies. Oversaw development of graphics, database, and content

integration with back-end systems. Hired and trained employees, set up

benefits systems, office operations, and managed client relationships.

. Established customizable system for clients resulting in growth to

over $1.5 M in two years

. Web 2.0 developer using .ASP. HTML, JavaScript, Visual Basic, Access,

and SQL.

** *** **

Prior success at Proxicom, Inc., consulting to PG&E and developing

Electronic Data Interchange protocol that was adapted in California energy

industry. Technical experience includes Microsoft Office, Acrobat,

CoreDossier, Visual Basic, JavaScript, SQL Server, Oracle, Visual C.

Education and Training

Ph.D. in Business MarketingEmphasis in Pharmaceutical Marketing (2012)

Capella University, Minneapolis, MN

Masters in Project Management (MPM) (2006)

Keller Graduate School of Management, Fremont, CA

Masters in Business Administration (2005)

Keller Graduate School of Management, Fremont, CA

Bachelor of Arts in Business and Psychology (1997)

University of California, Berkeley, CA

DIA Regulatory Affairs I & II Training

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