Experience

ProPharma

• United States
• Business Consulting and Services
• 700 & Above Employee

• Project Administrator, Regulatory Sciences

  • Jan 2017 - Present

  Note: Formally The Weinberg Group -- transition to ProPharma Group as of September 1, 2021 Primary Responsibilities: • Provide hands-on project management assistance and serve as document specialist for all U.S. Regulatory Sciences projects in various stages • Review/edit/format/finalize all FDA regulatory submissions (ANDA, IND, NDA, PIND, and Medical Device), as well as all outgoing scientific and technical client reports; ensure correctness and completeness of all submitted documentation; ensure documents align with correct FDA submission requirements and eCTD format • Collect, manage, and maintain CRM system project entries; manage filing and archival process of all documentation • Author/maintain SOPs, forms, and templates • Assist with document electronic publishing activities • Provide direct support for President, Regulatory Sciences when necessary Additional/Past Responsibilities: • Continually mentor/train Project Support team members • Schedule/participate in startup/closeout project meetings to document important project events and discuss lessons learned • Prepare/submit expense reports for clients, consulting staffs, and internal VPs • Maintain GCP/GMP audit records, subcontractor information/reports, and client information • Assist with review and finalization of outgoing business proposals to prospective clients Software/Databases Utilized: Deltek Vision, QuickBase, Microsoft Office (Access, Excel, PowerPoint, OneNote, Outlook, Word), Adobe Suite Show less



Axiom Resource Management, Inc.

• United States
• Information Technology & Services
• 100 - 200 Employee

• Technical Project Manager, Systems Architecture (Government Contractor)

  • Aug 2016 - Dec 2016

  • Provide operational and program management support to the Chief Architect as well as four additional government team leads in the sub-areas of Architecture, Data, Interfaces, and Requirements for the DoD Healthcare Management System Modernization (DHMSM) Architecture Branch• Develop, maintain, prepare, and track multiple technical action logs, artifacts, documents, and reports• Compile multiple types of data/information to complete deliverables and create presentations for use in government executive meetings; provide weekly and monthly status reports• Interface with stakeholders to obtain required documentation to maintain document libraries• Support product system interfacing• Schedule and facilitate product team meetings and technical system interface meetings; produce technical meeting minutes and status reports• Write and manage technical risks and issues• Manage technical documentation in various portals Show less

• Executive Assistant to the CIO (Government Contractor)

  • Sep 2015 - Aug 2016

  • Served as the Executive Assistant to the Chief Information Officer (CIO) for the Military Health System, as well as the Director of the Health Information Technology (HIT) Directorate for the Defense Health Agency (DHA), Department of Defense (DoD)• Additionally, assisted in the management of HIT Chief of Staff (CoS) and Deputy CoS's calendar• Conserved Acting CIO/Acting Director's time by reading and routing correspondence, drafting letters and documents, collecting and analyzing confidential information, and initiating telecommunications to internal and external parties• Maintained Acting CIO/Acting Director's appointment schedules by planning and scheduling meetings, conferences, teleconferences, and travel accommodations• Oversaw logistics of all meetings (daily, weekly, and monthly), to include preparation of all materials• Provided historical reference by developing and utilizing filing and retrieval systems• Assisted with preparations for professional office events• Completed research and writing assignments as requested Show less

• Project Coordinator (Government Contractor)

  • Oct 2014 - Sep 2015

  • Track project through its life-cycle including design, development, testing, integration, implementation, and sustainment• Track and Monitor all system test activities• Support application development vendor activities• Coordinate with Deployment and system operations teams to schedule and plan training, implementation and transition to support activities• Facilitate engineering reviews, to include tracking the resolution of issues and suggested stakeholder improvement requests• Support cost and progress reviews with the project scheduler and resource management controller• Maintain daily reporting mechanisms and all required documentation for the Product Team and Managers • Interface with stakeholders to obtain required documentation and maintain document libraries • Responsible for meeting coordination, taking meeting minutes and other associated duties• Support Department of Defense (DoD) acquisition activities• Support Commerical Off the Shelf (COTS) vendor interactions• Maintain detailed information for all points of contact and provide daily status updates• Prepare documentation using standardized templates ensuring all required information is complete and accurate• Route documentation for approvals from the Product Team to include engineering, information assurance representatives, and Product Team Lead• Schedule and attend weekly working group meetings with the Service Representatives to provide status updates of the interface approvals• Prepare written progress and status as required by the government Show less



Bracket

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Specialist

  • Jul 2011 - Sep 2014

  Note: Now Signant Health • Manage identification and resolution of clinical trial data inquires/data changes and communication to internal and external multi-function resources within project teams • Manage communications with client (e.g., pharmaceutical sponsor, CRO) and site personnel regarding site/study details • Own in-study/maintenance transactional project activities throughout entire project life-cycle (e.g., project variable fees, inter-department workflow assignment, issue escalation) • Prepare study materials, including system requirements, data transfer documentation, questionnaires, surveys, response sheets, and other documents as required • Coordinate and set-up data for system launch as assigned • Design and configure unique project systems and manage data for each assigned project, utilizing proprietary IT applications • Produce data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients • Facilitate the close-down and archival of system databases • Attend international large scale training events and facilitate training sessions • Coordinate with clients, vendors, and expert consultants to ensure all logistics, materials, and technologies necessary for successful training events are in place • Oversee project QC activities to ensure compliance within the enterprise Quality Management System • Work within project team to develop and implement process for projects • Prepare and maintain in-study project plans and data management plans which will be executed in collaboration with Project Managers • Provide weekly status reports documenting project activities, planned steps and issues • Track monthly and quarterly metrics (variable fee budgetary items) • Training and development of teammates • Contribute to the development, enhancement, and testing efforts for enterprise IT applications Show less



Alvernia University

• Higher Education
• 400 - 500 Employee

• Resident Assistant

  • Feb 2009 - May 2011

  • Provided educational and life guidance to resident students while encouraging responsibility and accountability• Built strong, healthy, residential communities which complemented and extended classroom learning and enhanced student academic success• Mediated solutions for various issues with successful outcomes• Created and organized monthly activities and programs for both small and large groups

• Laboratory Assistant

  • Sep 2007 - May 2011

  • Assist Director of Laboratory Services & Safety with various tasks as requested on daily basis• Set-up materials for student use during laboratory classes and research• Maintain chemical and biological inventories for laboratory classes and research• Perform safety checks on laboratory equipment (e.g., eye washes, showers, etc.)• Provide assistance to Chemistry and Biology Department professors upon request