Lindsay Joyner Email & Phone Number

Durham, North Carolina, United States

• Technical writing department founder and head leadership. Responsible for the global cross site implementation and oversite of the department involving continuous strategic planning, process improvement, and hiring, management, training, and scheduling of junior staff.• Responsible for creation and management of global bioanalytical operations templates in ZenQMS (Quality Management System) with a high focus on regulatory compliance with EMA and FDA guidance for industry regarding data summary, statistical analysis, and reporting (21 CFR Part 11, ICH GCP and M10 guidelines, 2019 White Papers). • Application of Microsoft Power Automation flow using Microsoft Teams, SharePoint, and other Microsoft applications to configure an automated cloud-based system used to manage report scheduling to meet hundreds of individual project timelines company-wide across multiple global sites. • Generation and review of GxP method qualification/ validation and bioanalytical study deliverables (data releases, reports, etc.) including high level data and statistical summary. Focus on large-molecule ligand binding immunochemistry (PK, ADA, and NAb) and biomarker assays but also familiar with LC/MS, gene therapy, qPCR, and ddPCR.• Microsoft Word and Adobe Acrobat subject matter expert; consulted with hundreds of colleagues across global sites and dozens of clients to solve document errors on an as needed basis. Created work instructions and provided recurrent global trainings on eCTD compliance.

Durham, North Carolina, United States

• Organize the activities and resources needed to meet precise timelines for multiple projects and clients by actively collaborating with different analysts/scientists, BPMs, QC, QA and Finance.• Generation and review of large molecule (PK, ADA, NAb) GxP method qualification/ validation and bioanalytical study deliverables (data releases, reports, etc.) using Watson LIMS database and information from study documents (clinical protocol, test method, analysis plan, SOP, etc.). • Participate in use, regulation and improvement of Watson LIMS to manage data and support sample accessioning.• Authorized in quality control (QC) review of raw data worksheets after passing QCT certification assessment. QCT review includes review of calculations, procedural steps and acceptance criteria of the assay to ensure accurate and compliant data documentation.• Document and maintain internal/external meeting minutes in conjunction with the organization of action items from client calls. In addition to other general client coordination and communication.• Recruitment and management of Study Coordinator personnel. Help in planning, directing and overseeing the daily operations of Study Coordinator(s) for assigned team. Acting as mentor/ “buddy” by offering advice and guidance for successful performance in the role.

Princeton, Nj

• Use of documents (e.g. protocol, test method, analysis plan, SOPs) and a custom 4D, Inc. 4th Dimension relational database to extract data and acquire project specific information.• Preparation and quality control review of method validation and bioanalytical deliverables (e.g. data releases and reports) according to agency requests.• Function as lead customer interface for project deliverables. Coordinate internal efforts to achieve project deliverables.• Sole reporting personnel responsible for immunochemistry validation and bioanalytical report template updates to improve efficiency and ensuring that templates remain up to date with current practices and regulations.• Become familiar with the policies and practices of Syneos Health, including familiarity with computer systems, SOPs and LOGs. Remain up to date with current EMA and FDA GCP/GLP and industry guidance’s.• Knowledge of Portable Document Format (PDF) tools including Adobe Acrobat Professional and ISI toolbox. In addition to extensive use and knowledge of Microsoft Office Suite.

Warren, Nj

• Assist the digital media manager along with the marketing and sales team in updating and maintaining the Salesforce account with regards to prospecting new clients and building client relationships. • Assist the Events team with event and conference preparation, including building speaker lists, event administration, and event registration tasks as well as researching and maintaining marketing/ event pipeline• Asset cleansing- taking client based documents and turning them into market materials

Greenwich, Ny

• Withheld the highest responsibility to maintain, monitor, and control the shop when the owner was not present; this included managing the staff and opening/closing the business• Decorated and customized dozens of ice cream cakes for sale at the shop, wholesale customers, and various other events• Interacted and provided customers with their orders in a timely and friendly manner; restocking and refilling supplies; being familiar with our hundreds of ice cream flavors

Easton, Ny

• As a group ski instructor taught beginners of all ages the sport of skiing• As a Little Colonel Instructor taught children of all skiing levels how to ski and how to improve their already known skills

Bachelor’S Degree, Biology/Biological Sciences, General

Activities and Societies: Pre-Dental Society; vice president of KANDD (Knights Against Neurological Diseases and Disorders); dean's list.

High School, 4.0

Activities and Societies: University at High School (UHS) Science, Math Club, Cheerleading