Project Management Continuous Improvement

DENISE M. AYCOX

**** ******* **. **. * Chula Vista, CA 91911 l 619-***-**** l ************@*****.***

EXECUTIVE SUMMARY

Enthusiastic regulatory professional who is motivated and pays attention to detail. A very dedicated employee who can multi-task and meet or exceed deadlines. Impeccable ability to learn quickly and excel. Operates with a strong sense of urgency and thrives in a fast-paced setting. Seeking a position in Regulatory Affairs that will further my professional growth and utilize my skills and knowledge to support the overall mission of the institution while focusing on continuous improvement.

System Familiarity:

Liquent InSight GTrack SharePoint RDMS InSight Viewer GILDA

QUALIFICATIONS & SKILLS

Knowledge of guidelines and regulations, as they apply to research, development, quality and regulatory; including but not limited to CFR Title 21 Parts 58, 203, 211, 299, 312, 314, 316, 810 and 820.

Extensive knowledge and understanding of IRB and Research regulations and compliance.

Currently pursuing a Master of Science Degree in Regulatory Affairs.

Knowledge of FDA and EMA guidelines.

Experienced in routine FDA submissions and Annual Reports.

Excellent skills in Microsoft Office, ORACLE, SMS, RDMS and Salesforce.com.

Effective project planning, implementation and management competencies.

Ability to communicate effectively both orally and in writing as they pertain to planning, assigning and supervising the work of staff and providing status reports as required.

Experienced in training staff with new processes and procedures.

Outstanding presentation skills.

RELATED TRAINING

Good Clinical Practices (GCP) HIPAA Workshop

NIH Protecting Human Research Participants Validation

Good Manufacturing Practices (GMP) FDA Audit Workshop

Sarbanes-Oxley Workshop (SOX) ICH Guidelines

PROFESSIONAL EXPERIENCE

GILEAD SCIENCES, Foster City

2014 to Present

Regulatory Affairs Associate, CMC

Responsible for the support of routine submissions to the FDA. Supported Annual Reports for products in various therapeutic areas. Familiar with form FDA 356h. Prepared submissions for Certificate of Pharmaceutical Product, including the completion of form FDA 3613b. Supported global filings by Reviewing (eQC) and verifying CMC eCTD sections for all regulatory updates and filings as required. Updated SOPs to reflect newly implemented processes and procedures. Assisted with the authentication process for Certificate of Pharmaceutical Product. Assisted in the drug-listing of products. Maintained and checked document inventory. Acted as a liaison for RA Global Lead and Regional Leads by scheduling and coordinating regulatory assessment requests for commercial and clinical change control approvals for various countries. Analyzed and edited documents to ensure submission readiness including proper writing style, grammar, and nomenclature. Reviewed cartons and labels to ensure proper information is displayed including manufacturer information and storage conditions. Responsible and acted as a point of contact for various projects.

Reduced the number of FDA rejections for CPP (Certificate of Pharmaceutical Product) compared to prior years.

Innovated new ideas that simplified archiving and documentation processes.

Streamlined processes for a more effective and strategic approach to exceed departmental expectations.

Met or exceeded weekly deadlines for FDA submissions

RESMED CORPORATION, San Diego

2007 to 2014

QA Data Coordinator

Contributed to various projects. Assisted with FDA audits. Wrote and edited SOPs. Responsible for reconciliations including product recall remediation. Assisted with the development and implementation of programs such as Salesforce.com. Effective in Project Management. Provided administrative support to various departments. Performed PowerPoint presentations. Provided support for specific products and medical devices. Assisted in providing reimbursement codes (HCPCS).

Proactively innovated ideas, suggestions and conducted projects to better our department, which supported continuous improvement.

Followed procedures and protocol for reporting and recording deaths or injury to the FDA.

Followed HIPAA guidelines to ensure patient information remained confidential.

Provided product knowledge and acted as a liaison to patients seeking assistance regarding the usage of their medical devices.

Managed projects throughout the department

Assisted with product development by Researching options for new mask prototypes for potential distribution in the U.S.

Assisted in the training of new hires and provided the essentials that would deem them successful once their training period was complete.

EDUCATION

GEORGE WASHINGTON UNIVERSITY, SCHOOL OF MEDICINE, Washington DC

2016

Master of Science, Health Sciences with an Emphasis in Regulatory Affairs

NATIONAL UNIVERSITY, San Diego

2014

Bachelor of Arts, Business Administration with an Emphasis in Project Management

UNIVERSITY OF CALIFORNIA, San Diego

2014

Specialized Certificate in Clinical Trial Administration

SAN DIEGO MESA COLLEGE, San Diego

2012

Associate of Arts, Business Administration

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