Remote Customer Support & Travel Accommodations
Resume:
PEARL A. HOWARD
**** ****** *** 317-***-**** Mobile
Youngstown, OH 44504 ************@***.***
PROFESSIONAL EXPERIENCE
ELI LILLY & COMPANY – Indianapolis, IN Global Scientific Communications – Sr. Specialist Regulatory – Fixed Term -06/2016-4/2019
• Support the administrative function for Taltz® and Mirikizumab regulatory medical documents.
• Write, edit, and perform document finalization for regulatory medical documents for global submissions.
• Maintain document tracker database for regulatory medical documents, which includes adding and editing document metadata, preparing report for resource allocation, and requesting updates from medical writers.
• Request outsourcing support for document preparation.
• Provide backup administrative support for Taltz® and Mirikizumab scientific disclosures including manuscripts, posters, presentations, abstracts, redactions, and maintain tracking systems (Datavision, Biomed Tracker, and Clear). RICHARD L. ROUDEBUSH VA MEDICAL CENTER – Indianapolis, IN Health Services Research & Development - Program Support Assistant 09/2009-06/2016
• Supported the administrative management, infrastructure, and data needs of internal and external customers.
• Provided support for the Stroke QUERI program which included: managing calendars, coordinating local and international meetings, obtaining official passports, researching and interpreting relevant grant policies, procedures, and regulations.
• Ensured documentation such as grant proposals, manuscripts, pamphlets, certificates, forms, graphs, or technical manuals are compliant with funding agencies (federal, state, and university) regulations and requirements; composing, proofreading, editing correspondence and documents to ensure proper content and or format including spelling, punctuation, grammar are accurate.
• Serviced as department subject matter expert on travel coordination, travel system functionality (Concur), government travel card program, government purchase card transactions; technical expert on the processing and data entry of personnel and payroll actions, department subject matter expert on database development and maintenance, MS Office Suite, Reference Manager, and EndNote functionality.
• Developed standard operating procedures, forms, and standard letters for administrative staff. Developed databases for tracking travel expenses and supplies for research projects for dissemination to coordinators and research staff. VA-Center for Applied Systems Engineering-Administrative Officer (Acting) 08/2013-07/2014
• Supported the administrative management, infrastructure, and data needs of internal and external customers.
• Interpreted administrative policies, developing and/or implementing local policies, defining administrative requirements, advice to top management on related issues.
• Performed administrative management requirements for the organization with varies functions. Applied new policies, provides advice on requirements, maintained administrative systems, and prepares administrative paperwork. Developed ad hoc and standardized reports, dashboards, and data visualizations; and identified and implemented continuous improvement in the efficient use of our data assets.
• Implemented and maintained project and program quality assurance processes. Served as Administrative Specialist within the Veterans Engineering Resource Center to provide advanced administrative support. Responsible for planning all administrative activities but not limited to eligibility, contracting, procurement, budget, timekeeping, and various reports.
• Gathered and analyzed facts draws conclusions from information and communicates information clearly, orally and in writing. Worked within timeframe to meet project deadlines.
• Established effective interpersonal relationships with all levels of medical center personnel. Subject matter expert in word processing, spreadsheet, and audiovisual presentation software, Microsoft Word, Excel, and PowerPoint. PEARL A. HOWARD
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ELI LILLY & COMPANY – Indianapolis, IN Medical Devices - Document Control Specialist, Medical Devices – Fixed Term -06/2005-06/2009
• Led departmental compliance with the Lilly Global Records Retention Schedule (GRRS) in accordance with federal and state regulations for medical devices (ISO 9001:2008 for quality system).
• Serviced as technical subject matter expert for record database development and maintenance; provided recommendations for annual GRRS revision; drafted detailed requirements for the new quality control/assurance records management database system (NetTrax) which were used “as designed” by the vendor/contractor; drafted requirements for mapping data for migration. Develop standard procedures for records management.
• Developed testing strategies and validation methods for system acceptance; reviewed and cleaned data for migration; developed standard operating procedures and process instructions as needed; monitored data to ensure consistency, identify analysis corrective and preventive action, and identify training needs.
• Supported change control database (Trackwise) implementation: qualified Trainer and Power User; reviewed procedures and identified process flow constraints; provided support for data migration. Supported Regulus database implementation: participating on the project team as business leader; provided support for data migration; executed validation/verification scenarios for system acceptance.
• Created project documentation, systems requirements, and flow diagrams. Coordinated data collection and analysis activities.
BRISTOL-MYERS SQUIBB MEDICAL IMAGING - Billerica, MA Regulatory Affairs - Contractor - 01/2005- 05/2005
• Serviced as subject matter expert on federal and international submission regulations and requirements. Assisted in the preparation of an European marketing authorization application (MAA), application, completed within time constraints.
• Recommended and guided the implementation of new/proposed practices throughout a pharmaceutical organization and healthcare system. Ensured that the organization is up to date on all system redesign initiatives and identifying areas of focus. Participated in the planning of projects for redesign system and collaborate in the development and documentation of goals and objectives.
• Analyze, evaluation, and recommendations were reviewed by management officials only for potential influence on broad agency policy objectives and program goals. Findings and recommendations accepted without significant change.
VERTEX PHARMACEUTICALS INC. - Cambridge, MA Regulatory Affairs - Contractor – 05/2004-09/2004
• Managed Regulatory Operations projects as assigned.
• Serviced as subject matter expert in the implementation of document management database system (Documentum) in accordance with federal and state regulations and requirements including: defined standard naming conventions for Clinical, Nonclinical, Chemistry, Manufacturing and Control (CMC), and Regulatory documents supporting submissions; developed standard operating procedure for the transmittal and filing of documents to the Regulatory Affairs Archive Room, standard operating procedures for the transmittal and filing of Clinical Documents, and standard operating procedure for the acceptance of documents to the Regulatory Archive; and managed bulk load process for legacy documents. Managed and coordinated various projects and program level operations.
• Delegated complete responsibility and authority to plan, schedule, and carry out major projects concerned with the analysis and evaluation of programs or organizational effectiveness. Exercised discretion and judgment in determining whether to broaden or narrow the scope of projects or studies. Made authoritative judgments and prepare effective analyses, briefings, and reports.
BIOGEN INC. - Cambridge, MA Regulatory Operations - Contractor - 12/2003-05/2004
• Managed Regulatory Operations projects as assigned. Assisted in the implementation of CMC submissions tracking system including: act as liaison for information transfer between Cambridge, MA headquarters and Paris, France field office; verified source data in Cambridge, MA and Paris France offices; defined submission categories to align with PEARL A. HOWARD
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applicable international and federal regulations and requirements; amend training manual; and provided summary of source data verification findings for validation package. Monitored project activities and resource to mitigate risks.
• Directed activities to improve and maintain performance measures and monitors related to the domain of access. Planned, implemented, and evaluated clinical, business, and administrative elements that affect performance measures. Research problems that affect the quality and efficiency of patient care delivery. Provided advice to operating managers and supervisors regarding the use of systems redesign tools to assist in accomplishing organization missions.
• Organized, compiled, and summarized data to develop routine reports to identify trends and opportunities for improvement. Recommend resolutions such as eliminating, adding, changing, or rearranging specific procedures, products, or services to more effectively utilize resources. Identify resource deficiencies based on study results and providing recommendations for improvement to supervisors and/or organization leadership.
• Identified, analyzed and made recommendations to resolve conventional problems and situations. BIOGEN INC. - Cambridge, MA Regulatory Operations - Manager, Regulatory Operations - 01/1999-10/2003
• Analyzed and evaluated major administrative aspects of substantive, mission-oriented programs.
• Managed the development and maintenance of Biogen's Regulatory Agency Submission System (Documentum) including: serviced as subject matter expert on database development and implementation as well as federal and international regulations for funding investigational research projects; managed the detail work effort for implementation of the electronic document management system upgrade.
• Provided leadership to the cross-functional project team comprised of executive team, technical team, research team, marketing team and contractors.
• Monitored project activities and resource to mitigate risks; coordinated vendor involvement and supported for system engineering projects and technology.
• Reported status and pending issues to executive team. Developed global standard operating procedures and guidelines for managing change control for system modifications/enhancements; collaborated with cross-functional team members to implement and monitor, maintenance practices at all organizational sites.
• Coordinated resources for global submissions. Assisted in definition of global resource requirements. BIOGEN INC. - Cambridge, MA
Regulatory Operations Supervisor, Regulatory Documentation System - 01/1996-12/1998 Documentation Specialist, Regulatory Operations – 01/1991-12/1995 Regulatory Assistant, Regulatory Operations -01/1987-12/1990 Word Processor, Medical Affairs -01/1984-12/1986
EDUCATION
Marian College-BA Business Administration (Management and Human Resources) US Regulatory Affairs Certification – 2007-2010
Various conferences and training related to regulatory affairs, clinical operations, document management, records management, and various software applications.
MEMBERSHIPS
Delta Epsilon Sigma - National Scholastic Honor Society AWARDS
Biogen's Chairman Award - Employee of the Year 1999 Eli Lilly Quality Advocate Award - 2009
Veteran Administration – Special Contribution Award 2011
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