Experience

Hurley Consulting Associates Ltd.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Document Database Manager

  • Jun 2015 - Present

  Expert in the preparation of INDs, NDAs, clinical study reports, and CTD summaries in eCTD format using electronic submission software in accordance with regulatory requirements. Ensured that quality documents were compliant with style guides and electronic specifications were accurate and produced in a timely manner. Implemented global and specific editorial changes to documents. • Formatted and compiled documents according to stipulated style guides and guidance documents for reports, assessments, regulatory submissions, including 3 electronic NDA submissions and 3 INDs. • Drafted Clinical Study Reports based on Protocols and SAPs. Prepared appendices based on the CMF for completion by Clinical, Biometrics, and Regulatory Affairs. • Compiled initial drafts of documents for internal review and editing including the addition of standard text, introductory paragraphs, etc. • Prepared tables, figures, and flow diagrams for inclusion in documents. • Created case report forms in Visio based on Clinical Protocols. • Wrote CRF and eCRF Completion Guidelines to be used by sites entering data into paper CRF and electronic databases during the course of clinical studies. • Responsible for development support for RegCheck, a cloud-based application for evaluation of reports and regulatory documents. Show less



Forest Laboratories (now Allergan)

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Technical Writer II / Documentation Specialist

  • Jul 2011 - Jun 2015

  Completed document management activities including documentation creation, formatting, approval, implementation, retrieval, version control, and obsolescing for Pharmaceutical Sciences division. Created new drafts and revised existing research and regulatory analytical specifications for APIs, drug products, excipients, and container closure components for review and approval by Pharmaceutical Sciences constituents including Method Development, Drug Characterization, and Clinical Packaging. • Developed a Data & Documentation tool used to track lifecycle of CMC documentation and to provide metrics on the status of SOPs and other document types to management. • Used information and data to create scientific reports and documents for pharmaceutical regulatory submissions. • Worked with Regulatory Affairs-CMC regarding documentation needs for submission activities. • Lead and provided support for company-wide projects associated with the management of documents through Documentum. • Provided training and assistance to Pharmaceutical Sciences personnel on Documentum and documentation requirements. • Represented the Documentation Group on project teams, process improvement teams, management meetings, and internal/external forums. • Prepared, coordinated, and managed the CMC documents for regulatory submissions including US and ex-US marketing and investigational applications. • Provided a strong working knowledge of regulatory (US FDA, EMEA, Health Canada) guidelines and applied these guidelines to CMC projects and submissions. • Collaborated with diverse functional groups to ensure fileability and acceptance of CMC sections. • Reviewed and provided budget support for 170 people in Pharmaceutical Sciences including material expenditures purchases and project management projects. • Regular review of expenses to stay within targets, correcting accounting errors thereby saving money across departments. Show less



Hurley Consulting Associates Ltd

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Document/Database Manager

  • Jun 2006 - Mar 2011

  Formatted documents prepared and received by Hurley Consulting according to stipulated style guides for reports, assessments, regulatory submissions, including 3 electronic NDA submissions, 1 paper NDA submission, 4 INDs, 1 FDA advisory board meeting, and 1 Department of Defense grant proposal.• Organized procedures between Regulatory and Scientific Affairs to create an internal electronic submission process. Successfully provided electronic submission to FDA and received access to submit electronic submissions through ESG, leading to the FDA approval for company’s first NDA in eCTD format.• Formatted and compiled documents according to requirements specified by regulatory agencies.• Prepared annual reports (IND and NDA) including the Chemistry, Manufacturing, and Control (CMC), clinical, and nonclinical documents.• Compiled initial drafts of documents for internal review and editing including the addition of standard text, introductory paragraphs, etc.• Prepared tables, figures, and flow diagrams, templates and document shells for inclusion in documents.• Bookmarked and hyperlinked electronic documents prepared or received by Hurley Consulting according to client and regulatory agency specifications.• Produced slides for presentations made at internal and external meetings.• Generated and maintained tracking documents for tables and figures to be included in reports. Show less

• Supervisor Document/Database Manager

  • Feb 2000 - May 2006

  Lead coordinator Supervised up to 8 employees in the preparation of INDs, NDAs, clinical study reports, and CTD summaries in eCTD and paper NDA format. Provided support to the pharmacology, toxicology, chemistry, clinical, biometrics, and regulatory areas of the company. Ensured that quality documents were compliant with style guides and electronic specifications and were accurate and produced in a timely manner. • Formatted documents prepared or received by Hurley Consulting according to stipulated style guides for reports, assessments, regulatory submissions, including 5 electronic and 8 paper NDA submissions and 4 INDs.• Evaluated company standard operating procedures for internal compliance. Show less



Prebon Yamane (USA) Inc

• Banking

• Administrative Assistant

  • Apr 1997 - Jan 2000

  Provided administrative support for legal and compliance departments. Provided backup support for CEO. Drafted employee contracts, termination agreements, joint venture agreements, consulting agreements, and all other business/legal correspondence. Researched issues for Senior Vice President and General Council and CEO. Finger-printed employees for compliance records. Screened telephone calls and took messages. Scheduled appointments and travel arrangements. Typed, filed, took dictation, and compiled expense reports. Show less



Cravath

• United States
• Real Estate

• Associate Secretary

  • May 1996 - Apr 1997

  Drafted and revised legal agreements. Responsible for all business correspondence. Screened telephone calls and took messages. Scheduled appointments and travel arrangements. Typed, filed, and took dictation. Drafted and revised legal agreements. Responsible for all business correspondence. Screened telephone calls and took messages. Scheduled appointments and travel arrangements. Typed, filed, and took dictation.