SUMMARY:

• Highly motivated and quality - driven Project Management and Technical Writing Specialist with over 3.5 years of Clinical and Pharmaceutical experience with extensive technical writing, critical thinking, and problem solving skills with a high proficiency in effectively implementing and executing technical projects and timely completion of accompanying validation and quality documents.
• Project planning/coordinating subject matter expert with exceptional organizational and time management skills with the proven ability to work productively, both independently or within a team, while meeting critical project deadlines for timely completion of high priority quality/validation projects directly supporting Clinical Trials (phase III) .
• Project planning/coordinating subject matter expert with exceptional organizational and time management skills with the proven ability to work productively, both independently or within a team
• Comprehensive in-depth knowledge of drug development processes and local management of clinical trials (Phase III) with the ability to work on multiple trials in parallel with solid project management and a flexible mindset which thrives best in a fast-changing work environment
• Excellent communicator with solid leadership skills and the ability to successfully lead initiative/small teams
• Clinical trial coordination and management experience in Phase III clinical trials with a focus on patient recruitment and patient retention.
• Experience includes the implementation of study protocols, compliance with FDA regulations and Good Clinical Practices through project management, coordination and patient recruitment.
• Operational focus consists of analyzing sponsor specific contracts to maximize revenue and deliver clinical study randomization goals.
• A summary of proficiencies are as follows:

SOFTWARE:

• Expert proficiency in the following software programs:
• Microsoft Office Suite (Word, Excel, Outlook, Project, PowerPoint, Sharepoint, Access, and more), Adobe Acrobat Professional
• Trial Management Systems
• SAP, TrackWise,Visual Analytics, JIRA, Recruitment Manager, Retention Manager, Dynamics SL, Clarizen, Tableau, eDoc, ISOTrain, TruVault,Gemba, Salesforce, and Clingphone

PROFESSIONAL EXPERIENCE:

Project Manager and Commissioning Lead

Confidential, Valley Forge, PA

Responsibilities:

• Writing and execution of Commissioning Test Plans for a variety of equipment including Feed Water Conditioning Units, Heat Exchangers and HVAC units, all integrated with various BAS and EMS control platforms
• Extensive Project Management responsibilities managing between fifteen-thirty commissioning projects at a given time with a fortune-500 Pharmaceutical company
• Directly performing commissioning duties with and without direct supervision including performing detailed technical reviews of construction documents
• Representative of the commissioning team for RPA with managing including client interface, team coordination, and schedule & budget management
• Oversee development of high quality commissioning plans, reports, and functional test procedures

Technical Writer & Validation Support

Confidential, Swiftwater, PA

Responsibilities:

• Project Manager with extensive technical writing and problem solving skills implementing and executing technical and project documents associated with projects including, but not limited to: continuous process and product quality improvement (material/vendor supply), equipment process, and product quality validation, protocol generation/execution, and verification activities
• Write and revise technical documents (SWI’s, SOP’s, Batch Records, Change Control (CC) Requests, Specifications, CAPA’s, deviations, Flow Diagrams, etc.) to support current procedures of the Viral Manufacturing platform and continuous improvement department
• Manage quality systems (change control, deviation management, cGMP documentation) within viral manufacturing to meet established requirements
• Technical author and quality reviewer of various quality, compliance documents and validation reports to support critical Continuous Improvement projects directly supporting Viral and Bacterial Vaccine Operations at the Swiftwater site.
• Project Management of all document creation and revision within Confidential testing platforms, managing timelines for review and approval of documents
• Interfacing with external suppliers, vendors, amongst various other sourcing activities.
• Proficient Technical Writer , Project Management, Root Cause Analysis and CAPA development
• Proactively identifying and driving Continuous Improvement projects by utilizing statistical analysis and data driven ability to interpret results and trends in data relative to processes to drive a more robust performance

Clinical Trial Project Manager

Confidential, Horsham, PA

Responsibilities:

• Provide oversight of a study from award to closeout to ensure progress according to study timelines and proper documentation by acting as a liaison between business development, finance, marketing, IT, materials, contractors, vendors and our global leaders.
• Ensure proper collection and validation of data and documentation in a timely manner
• Coordinated with PPD to deliver patient recruitment materials and necessary translations in accordance with strict IRB/EC submission deadlines; tracked all submissions to adhere to global regulatory requirements
• Organize and lead study specific meetings on a weekly and monthly basis, including attending Investigator Meetings and presented the benefits of retention services to clinical site staff
• Project and data management activities, including data review and analysis, both clinical & operational, to propose actions, and coordination of the final study report cascaded to teams cross-functionally
• Develop and maintain an optimized study planning with other functions (including identification of critical path)
• Manage and utilize multiple Acurian’s internal software platforms including salesforce, Jira, SAS, and Tableau
• Proactively collaborated with leadership teams to introduce and discuss continuous improvement projects and present potential solutions to problems, such as historical data associated with the calculations and master data migration to assist in a streamlining process for this project
• Analyzed contract and actual funnel rates to identify opportunities and risks; escalated potential impacts to project margins to senior management.
• Project planning, analysis and projections of project timelines and financials (CRO, Sponsor and customer management)
• Ability to effectively interact with scientists and managers within and outside Clinical Sciences Organization (CSO), serving as internal Subject Matter Expert (SME) consultant on assigned area, liaising with external vendors and organizations for project work
• Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
• Provide project initiative support including: documentation, monthly/weekly reports, shipping, filing, tracking, and status outline, as appropriate
• Reviewed ICFs in accordance with regulations and maintained accurate storage of TMFs based on CFR Title 21
• Track, maintain and update the lifecycle of a project and are meeting all projected milestones, and deadlines
• Consistently reviewed IVRS data and met with management to identify opportunities to enhance not only randomization goals and exceed client expectations, but opportunities to increase revenue for the company
• Coordinates the development, printing, shipping, and tracking of study binders and marketing materials.

Technical Specialist, Quality & Performance Excellence

Confidential, Skillman, NJ and Fort Washington, PA

Responsibilities:

• Compile the product’s yearly production documents and analysis of release data, stability data, product complaints, investigations and related documents to verify consistency of the process by conducting the Annual Drug Product Review/Annual Product Review (ADPR/APR) to assess trends and note any observations that could indicate any changes in product or production.
• Facilitate communications between External Manufacturers and J&J business partners to ensure report content is accurate and complete.
• Managing and creating a precise timeline with stakeholders to guarantee milestones and key dates are accomplished
• Subject Matter Expert (SME) for Annual Product Reviews (APRs); provide key quality indicators to management and represent the process during audits and health authority inspections.
• Track and monitor multiple process steps/report progressions simultaneously to consistently achieve on-time completion of APR reports; provide status updates to Management regarding reports in jeopardy of not meeting timelines, outstanding action items, and escalation of issues
• Lead and participate in a weekly team meeting to discuss our monthly ADPR/APR progress & pain points, project sharing, best practice sharing, innovation and process improvements.
• Coordinate, compile and analyze APR Report contributions, including manufacturing and laboratory investigations, product quality complaints, stability data, product quality related returns, change controls, specification changes, validation activities, etc.; troubleshoot quality and compliance issues with strategic engagement of business partners.
• Revise and/or develop new SOP documents to support new processes and work instructions while adhering to Confidential and Confidential ’s policies and best practices under a tight schedule to meet required deadlines.
• Perform statistical analysis of internal or external manufacturer data included in the APR as applicable; identifying and addressing shifts and trends as necessary.
• Extensive use of MS Word, Symphony ETQ, Sharepoint, EDM, & GSS software & systems.
• Collaborate with project team members with the project of streamlining annual product reports/Annual Drug Product Reports (APR's/ADPR’s), transition the APR report to Tru document system, and create/implement work instructions pertaining to the appropriate site and update SOP’s in relation to the transition

Quality Analyst, Confidential Support

Confidential, Sellersville, PA

Responsibilities:

• Implementing Confidential and computer system validation in a cGMP pharmaceutical environment.
• Participated in the Labware to Labvantage Confidential migration project by analyzing current and historical data and validating calculations for review and approval by management
• Oversaw the data migration process and ensured compliance with the SOP for the Confidential project
• Cross functional collaboration with teams regarding data migration, data integrity, master data, and quality management.
• Initiated and authored CCs in compliance with cGMPs
• Analyzed and reviewed audit trail history for validation completion
• Proactively collaborated with leadership teams to introduce and discuss continuous improvement projects and present potential solutions to problems, such as historical data associated with the calculations and master data migration to assist in a streamlining process for this project

Food Quality and Safety Analyst

Confidential, Allentown, PA

Responsibilities:

• Reviewed and tested raw materials of product ingredients and finished products for conformance to validate that our product meets our standards by pulling random samples off the production line
• Tested and document samples of raw materials, products in process, finished products, water and other samples provided by various departments to help ensure quality in the manufacturing process
• Root Cause Analysis of Quality deviations and implementation of CAPAs with corresponding effectiveness checks
• Shipping samples to various external laboratories for testing and analysis when required
• Adhered and revised documents, labeling, and production compliance with FDA regulations and cGMP guidelines