SUMMARY

Regulatory Submissions Assistant with experience in the pharmaceutical industry. Proven expertise in areas of submission publishing and QA on all submission documents. Outstanding trouble-shooting, problem solving and documentation skills. Excellent ability to communicate and collaborate with all levels of staff and “customers”. Demonstrated knowledge of CBER and CDER paper and electronic submission requirements and report structures, i.e., IND, NDA, BLA, CTD and some eCTD. Comfortable working independently or in team environment.

Additional skills include:

· Attention to Detail · Team Lead / Team Player

· Analysis · Knowledgebase Implementation

· Mentoring / Knowledge Transfer · Software Installation / Conversion

(Training of new staff)

TECHNICAL SKILLS

CoreDossier, Adobe Acrobat, Compose, EZ-Pub, ISI ToolBox, Documentum, First Docs, Lotus, Windows (XP, 2000, NT), scanning, PRIMUS, ISO 9000, Word, Excel, Progress 4GL / RDBMS

PROFESSIONAL EXPERIENCE

GLAXOSMITHKLINE (Bogier Clinical & IT Solutions), Philadelphia, PA 05/2008 – 12/2009

Regulatory Submissions Assistant

· Publish wide range of electronic clinical report submission documents (involves TOC, bookmark, hypertext link creation), using CoreDossier, Documentum, and generating Adobe PDFs in accordance with FDA regulations/guidances in a timely, accurate manner. Publish clinical study reports, summary documents, Biologic submission documentation, non-clinical docs, paper, electronic, CTD, and some eCTD reports.

· Liaise with other groups to resolve publishing issues such as incomplete, incorrect or corrupt source files, improper content or format of documents, and other problems as they occur. Retrieve and return secure docs to submissions document repository.

· Improved SOP and training documents to enhance performance of quality assurance and compliance checks, using advanced Adobe Acrobat techniques on various clinical and other pharmaceutical studies to eliminate errors prior to FDA submission.

CEPHALON Inc (Devon Consulting), Frazer, PA 01/2008 – 03/2008

Regulatory Publishing Associate

· Publish electronic clinical report submission documents (involves TOC, bookmark, hypertext link creation), using First Docs, scanning, and generating Adobe PDFs in accordance with FDA regulations/guidances in a timely, accurate manner.

· Assure adherence to global regulatory requirements as they pertain to document creation, organization, format, and standards.

· Manage the architecture and documents for regulatory submissions within the document management system (Documentum / First Docs).

GLAXOSMITHKLINE (ZeroChaos), Philadelphia, PA 10/2005 – 01/2008

Regulatory Submissions Assistant - Same as GlaxoSmithKline tasks described above.

CONSULTING (freelance) 11/2004 – 09/2005

· Implemented software installations, upgrades, networking and testing for various Property Management and Fulfillment organizations.

QAD Inc, Mt. Laurel, NJ 06/1992 – 09/2004

(Major manufacturing supply chain ERP software (MFG/PRO) developer)

Technical Support Consultant 1998 – 2004

· Led the “Black box” (Pre-release) Testing Team for installation of important new software release, resulting in fewer problems and greater customer satisfaction.

· Tested installation of Service Packs for quality before being released to customers, which resulted in fewer calls to the Helpdesk and reduced company expense.

· Acted as technical group expert in making design decisions for development of knowledgebase. Crafted over 100 knowledgebase solutions.

· Trained and mentored Support Team on the use of Primus, third party software for using knowledgebase solutions and then how to create others which resulted in the

increase of knowledge for the support team and increased customer satisfaction.

Technical Support Analyst 1996 – 1998

· Implemented installation of software and program launch of a Solution knowledgebase system to be used globally by the company and our customers.

· Crafted over 100 knowledgebase solutions, which were used thousands of times and resulted in the reduction of customer calls and increased customer satisfaction.

· Resolved customer’s database crashes and other problems called in on the phone, which resulted in customer satisfaction and contributed to customer retention staying at 98%, exceeding Gartner Group standards.

Customer Support Analyst 1994 – 1996

· Analyzed customer’s custom PROGRESS 4GL code when Help ticket submitted.

· Documented, analyzed and worked on customer issues for Technical Support.

Custom Code Support Representative 1992 – 1994

· Analyzed customer’s custom PROGRESS 4GL code when problem submitted.

SAM GOODIE (Musicland), North Wales, PA

Sales Associate

· Sold music CDs and other music items, and was knowledge source for customers.

JAMES RIVER CORPORATION, Southampton, PA

(Major paper and consumer packaging manufacturer)

Programmer / Analyst (Specialty Business Papers)

· Created Help system for customer service / data entry and sales using Microsoft Windows and Visual Basic Help Compiler.

· Designed mill capabilities system using Alpha Four 4GL / RDBMS.

Production Planner (Specialty Business Papers)

· Planned/Scheduled production for paper machines.

Inside Sales Representative (Specialty Business Papers)

· Sold and arranged delivery of specialty papers to customers.

JAMES RIVER CORPORATION, Norwalk, CT

Capital Administrator (Towel & Tissue Group) - Improved Focus 4GL system report output.

Systems Analyst (Focus 4GL / RDBMS)

Scheduler/Change Control

DURACELL INC, Bethel, CT

Supervisor / Problem Coordinator - Operations Support

· Cross-trained and conducted performance reviews for all OS employees. Improved morale and customer service, which transformed the department’s reputation for service and competence from the worst to one of the best in the company. Primary contact for all data center concerns.

EDUCATION

Western Connecticut State University, Danbury, CT

BA, Speech Communications / Theatre Arts (Directing)

MILITARY EXPERIENCE

UNITED STATES NAVY

Data Processing Technician – 4 Years Active duty - USN - Honorable Discharge