Laurie Silverson

• Lead in process improvements and QC to build accurate regulatory histories • Veeva RIM process authoring and editing as well as archival • Project management from the operations perspective • AI experience to understand collaborative data in the pharmaceutical context – building study designs

• Led the framework and process for PleaseReview implementation – start to finish • Word and PDF formatting for submission-ready documents • QC of submissions of eCTD submissions (all modules) • Collaborative with all cross-functional teams to meet deadlines

• CTR harmonisation within a Rapid Filing Team (RTF) structure to strategically plan, submit, & transition (when necessary) active clinical trial documentation in CTIS • Understanding of key factors classifying substantial & unsubstantial modifications to assess their impact • Responded to RFIs in a time-sensitive & strategically measured manner ensuring team consensus & continuance of study activities • BLA support & strategy for early FDA engagement meetings

Clementi & Associates Ltd. (Director) - Clients Confidential - 2014 - 2024 EG Life Sciences (Eli Lilly), IPG (AbbVie, Eli Lilly, Pfizer, AZ), inSeption Group Core Offerings: • Creation of (including content development, formatting [Word, PDF], electronic publishing, & validation) submission-ready documents & published eCTD output for delivery to Regulatory Health Authorities • Expertise in complex submission types & guidelines for multiple Regulatory Authorities & Divisions (eCTD m1-m5) in paper or electronic format • Medical & Technical Editing, Data Integrity, & QC of Regulatory Documents & Publications • Transitioning businesses (both small & large) from paper to electronic submission format by executing a comprehensive transition plan that addresses administrative/legal, technical, training, & operational requirements • International Outsourcing Leadership, Global Training Initiative Leadership, Project Management, Team Management, Mentoring, & Career Counseling • Clinical Trial Management and Trial Master Files • CRO & Vendor Management • Responding to time-sensitive Information Requests • CMC Audit Support (non-GMP & GMP) and CRO Vendor Site Audits • Project Management & Client Interface • Extensive Experience Working Across Applications for Efficient Cross-Referencing Relevant Content Submission & Guidance Expertise: eCTD (m1, m2, m3, m4, m5), FDA, ICH, CDER, CBER, DMF, VCRP, BB-MF, Pre-IND (including FDA meetings), SPL, CDRH 510(k), Q Submissions, CVM, EMA, AMA, ICH, SOP development, eTMF, PRO Assessment Tools, VCRP, & US Congress & Medical Publication Guidelines Tools & Software Expertise: Microsoft Suite, Adobe Acrobat Pro, GlobalSubmit, Extensive Veeva Vault RIM & Veeva Quality Docs, Veeva PromoMats, Docubridge & Lorenz, EDMS/Documentum, ESG, FDA eSubmitter, ISIToolbox, SharePoint Development, FURLS, Egnyte, SmartSheet, ViewPoint, CDER NextGen Portal, VCRP, CDERDirect SPL & Registrations, Evermap, Workfront

• Managed submission content & accountable for the receipt & workflow completion of all submission components, resulting in a high-quality final product • Head Global Liaison representing the US in Accenture’s Global Office Initiative championing the rebranding of an international office while adhering to smart, global workload management • Developed milestones, timelines, & budget; relayed these objectives to the team & client to ensure team success, budget adherence, & client approval & retention • Conducted reviews, mentored, & provided career counseling to direct reports

•Formatted, edited, & performed QA (content fact checking & data integrity) for documents submitted to regulatory authorities (clinical), Lilly poster presentations, peer-reviewed journal abstracts & articles, as well as maintained literature libraries by therapeutic area. •Served as the chief liaison between medical writers & editors, maintained workload documentation, & assigned all editorial work

• Managed US & international editing activities • Performed expert-level proofreading & editing, including formatting, consistency, accuracy, & organizational checks for regulatory documents • Designed & implemented a rigorous training program for new employees • Designed new workflow software in SharePoint transforming the tracking of international work • Thorough knowledge of document templates, ICH, & other applicable guidance supporting regulatory, medical & scientific documents, client-specialized templates, &/or client style guides

• Provided submission standards, guidance, & tools to enhance the creation of consistent, reviewer-friendly documents, while improving the process for the authoring community & reducing rework related to submission-ready compliance • Selected as a submission-ready Subject Matter Expert to set companywide FDA & EMA submission standards & best practices as well as conducted global training initiatives • Legacy Wyeth & Legacy Pfizer Harmonization: Key player in establishing the Submission Ready Business Line Forum

Independent Contractor and InVentiv Clinical • Formatted documents (approx. 100 document types) to make submission-ready (Word, PDF, eCTD, & paper format) for Regulatory Health Authorities • Developed Doc Tech’s compliance standards & processes with the creation & maintenance of Document Processing Guides & Work Practice Guides • Managed the US, India, & China Doc Tech groups & positioned as the chief contact between the international Doc Tech groups & clinical writers, biostatisticians, & senior management. • Responsible for decommissioning Doc Tech which included generating formal communications to global customers, analyzing the business impact of exit, training for affected departments, & archival

• Lead technical editor responsible for the creation of FDA submission-ready documents • Managed and trained the Synchrogenix offsite team of technical editors and medical writers • Worked with IT team to employ Documentum across multiple projects and design successful project workflows

Overall GPA: 3.8 (Honors Degree with Distinction, Cum Laude) Major GPA: 3.9