SUMMARY:

• Incisive Decisions - Makes good timely decisions based on project management experience, analysis and judgement. Excellent planning and problem-solving skills based upon project priorities, budget and goals. Ability to adapt plans to changing project and business requirements.
• Results Delivery - Establishes clear goals and performance standards with metrics for myself and teams; exhibits creativity and resourcefulness in resolving challenges; organizes work to ensure high impact/high value activities receive priority; hold myself accountable for meeting organizational and performance goals.
• Impact and Influence - Excellent business and scientific communication, presentation and writing skills targeted to audience background, at all levels of an organization. A consensus builder among teams and across divisions with differing agendas and priorities. Sensitive to cultural differences in work styles and approaches to negotiations. Fluent in Spanish
• Experience - Team player who works well under pressure, motivates others, and takes initiative for deliverables to meet goals. Self-motivated with a sense of urgency and very strong work ethic.

TECHNICAL SKILLS:

PROJECT MANAGEMENT: PMBOK; SDLC; Lean and Six Sigma, MS-Project; Storyboards; Brainstorming; requirements gathering and analysis; specification development

SOFTWARE TOOLS: Microsoft Office (Word, Excel, PowerPoint, Access); Visio; Cognos (accounting); WebEx; GoToMeeting; Google; Lotus Notes; Planisware; Trackwise; IBM Watson; HTML &XML web development

BUSINESS: Significant business experience (10+ years) in strategic planning; client relationship development. Responsible for external and internal stakeholder relationship management; vendor management; writing/responding to RFPs/RFIs; program/project management (short term 1-3 months, long term +12 months); business process development, reengineering and change management; leadership by example; mentoring; building and guiding teams and tools that enable departments to function successfully.

PROFESSIONAL EXPERIENCE:

Senior Regulatory Affairs Specialist

Confidential

Responsibilities:

• UDI and Medical Device Compliance: Managed team’s entry of UDI information for type II medical devices to meet FDA deadline. Personally completed +30 UDI Type II device forms. Reviewed team’s completed UDI forms for accuracy, compliance and readiness for submission. Developed and presented half- year and annual reviews.
• :Developed onboarding for new hires. Wrote work instructions for team to complete Product Model (PMI), Regulatory Body (RB) and other complex data entry tasks; reduced error rate by 30%. Trained RA Specialists in the use of GEHC Regulatory Affairs platform - International Regulatory Information System (IRIS), MyWorkshop, and GE Forms.
• Agile Project Manager: SIMS GEHC - manage development of next generation user manual access system that provides product owners and field engineers with secure access to role appropriate information and maintenance notification across GEHC ITCE team. Managed TCS team and TCS competitors. Worked with offshore and onshore teams to realize Sprint and project goals.

Regulatory Affairs Associate

Confidential

Responsibilities:

• Provided consulting services that include protocol development, preparation of IRB submissions and regulatory affairs oversight. Conducted literature reviews and drafted scientific and technical documents under the direction of clinical consultants and other members of the client’s team; served as a liaison between IRB review committee and client. Conducted client research for non-dilutive funding on contracts and grants, and any additional consulting work required by clients.
• Would have monitored site as CRA for a European clinical trial in Spain, and provided regulatory submissions (eCTD, 510k, PMA, CE Marking, 93/42/EEC Quality Medical Device Directive, ISO 13485:2003 Quality Sys, IRB submissions, etc.) and updates had project progressed.

Clinical Trials Project Manager

Confidential

Responsibilities:

• Directed progressively more complex, multi-center, national and international protocols according to FDA, ICH and other regulations; facilitated sponsor expectations and knowledge transfer for protocol among sponsors, CRO and clinical sites. Proven ability to prioritize multiple tasks and protocols through effective time management and project management skills.
• Conducted literature reviews and drafted scientific and technical documents; served as a liaison between protocol review committee and client. Assessed technical feasibility of protocols at proposal stage, contributed to protocol and edited protocols during development; acquired timeline & database specifications from client, post-; produced specs for & reviewed database design documents; POC for investigator site questions.
• Developed site and presented at investigator meetings; reviewed case report forms, site documentation, lab data transmissions for clinical signals/AEs/SAEs, led database close-outs, and provided written summaries for INDs, NDAs, ANDAs and eCTD.
• Operations: ensured enrollment and visit kits shipped on time, and tracked sample shipping, processing and data; exceeded expectations for problem prevention/resolution. Negotiated vendor deliverable milestones.
• Project Management: Provided excellent customer service; met budget, milestones and client deliverables; provided weekly project status updates to stakeholders; tracked and reported monthly budget trends; developed method to present budget burn rate in three lines; recommended and implemented solutions identify risk. Projects closed on-time and within budget.

Student/Research Assistant/Intern

Confidential

Responsibilities:

• Quintiles Transnational, Full-time, Paid Intern-CTA. Reviewed principal investigator (PI) files for completeness in preparation for close of clinical trials; located and sent missing documents to CRAs. Ensured all regulatory documents for ongoing and closing trials were correct and in files. Took and published notes for CTA and CRA teleconferences. Assisted senior CTA with other duties as required during site close. Observed several site initiation and startup visits with CRAs including site, supply documentation and storage, site file management and Confidential t recruitment discussions.
• CDC, Research Intern. Assisted in the development of a Salmonella O-, H1- and H2- group-specific DNA BioPlex assay to detect the most common serogroups in the United States plus serotype Paratyphi A. Conducted literature searches to understand lab methods, experimental design, and contribute to lab writeup. Co-author on a presentation to American Microbiological Society 06/2008. BL2 certified.
• Biology Department, Research assistant, in lab studying Nitric Oxide Synthase (NOS), required the resolution of technical and experimental problems with minimal supervision. Set up the lab and re-established cell lines after a re-location; set up and maintained Linux cluster for a bioinformatics /computational biology course; sterile cell culture, production of mutants by overlap-extension PCR, protein purification by column chromatography, quantified protein yield using spectroscopy, and characterized protein binding site. Wrote SAS code to analyze datasets; ed student stipend to attend SAS convention in Atlanta. Created database to store and analyze experimental results using MySQL.
• Psychology Computer Lab, Student Assistant, 2006, Answered students' questions about technical writing, the use of statistical packages (SAS, SPSS, Minitab) to analyze lab data, and proper application of the APA Style Manual..
• Full-time student, Biotechnology and statistics

Research associate

Confidential

Responsibilities:

• Ran simulations of molecule docking with cell receptors in a computational biochemistry lab. Used molecular modeling and ligand docking packages such as Sybyl, Amber, and Macromodel to study potential new medicines. Conducted literature searches to prepare documents for submission for grant funding. Taught graduate students how to use modeling & docking software. Maintained and patched lab UNIX servers.