Clinical Research Regulatory Compliance
Resume:
Jackie Emanuele
Tucson, AZ *****
*******@*****.***
Professional Summary
• Results-oriented professional with extensive experience in writing, editing, and project/program management. Adept at managing diverse projects, coordinating with stakeholders, and delivering high- quality content.
• Exceptional collaboration and interpersonal skills, ensuring seamless collaboration among stakeholders
• Demonstrated ability to manage and execute programs in a deadline-driven environment
• Exceptional marketing writing and social media communication skills
• Ability to turn complex information into concise, comprehensible documents and articles
• Proficient in content creation and production tools, including Microsoft and open source/SaaS software to include maintaining shared documents in various systems, including RedCap.
• Innovate by using best practices, style guides and other collateral for marketing and technical documentation.
Work Experience
Clinical Research Internship
Arizona Liver Health-Tucson, AZ
February 2025 to Present
• Assisted in the coordination and management of clinical trials, ensuring adherence to protocols and regulatory requirements
• Collaborated with cross-functional teams to ensure timely initiation, enrollment, and completion of clinical trials
• Performed data entry and quality control checks to ensure accuracy of collected data in electronic databases or systems
• Participated in investigator meetings or training sessions to provide guidance on protocol implementation procedures
• Ensured compliance with Good Clinical Practice (GCP) guidelines throughout all stages of clinical trials Owner, Project Manager, Program Manager, Writer, Editor EEC, LLC-Seattle, WA
July 2007 to Present
• Provide business development, content development, and editorial project management for key clients and subcontractors.
• Deliverables include learning modules, user manuals, how-to guides, getting-started training, and similar content types.
• Clients include Denali Advanced Systems, GarbleCloud, Scalewise Media, Pearson Digital Learning, Kemp Technologies, Active Learning Technologies, University of California, Davis, Linbit Linstor®, and others.
• Exemplary record for outsourcing and handling vendor IT resources and subcontractors.
• Individual front-line contributing, as well as scoping content projects and providing status updates. Writer, Editor for FIS Worldpay
Eliassen Group-Remote
November 2021 to December 2022
• Aggregated and edited content for User Guides, Product Overviews, Release Notes, and Enhancement Guides for FIS World Pay, Modern Banking Platform.
• Member of Editorial Board responsible for FIS Style Guide.
• Responsible for WIKI page updates using Confluence/JIRA. Writer/Editor for SAP Concur
Murphy and Associates-Bellevue, WA
August 2019 to January 2021
• Compiled data for NIST-800-53 compliance policies and standards for SAP Concur for internal and external audits. (Other compliance frameworks included were SOC-1, SOC-2 and ISO 27001.)
• Identified gaps in SSP and became primary technical document owner for SSP under the Controlled Documents Lead reporting to the CISO.
• Recrafted incident response plan and Department of Defense (DoD)/FedRAMP+ System Security Plan
(SSP). (Document length: 500 pages)
• Initiated stakeholder communication and reporting on content development efforts consisting mostly of internal SME and control owner interviews.
• Provided graphics support and layout
• Partnered and provided crucial support to legal counsel; Incorporated legal counsel revisions.
• Cross-collaborated daily with Application Security, Privacy (App Sec lead) for SSP insertions related to cybersecurity.
Editor for Microsoft Inc. and Mobile Integration Workgroup MAQ Software and Mobile Integration Workgroup-Redmond, WA July 2018 to July 2019
• Provided strategy and consultancy for an internal MIW branding initiative.
• Vetted consultancy houses and offered support for voice and tone; crafted responses for a marquee customer in the IT Telecom space.
• Gathered information and ghost-wrote blogs, including examples such as: https://mcellblock.com/ device-testing-in-mixed-environments/.
• Supported Microsoft as a client to develop the Azure internal operations ecosystem onboarding guide version 1.0.
Project manager, writer, and editor for Microsoft Xbox UniVentures-Scottsdale, AZ
June 2013 to July 2014
Redmond, WA.
• Scoped, planned, wrote, and edited user manuals for the Device and Entertainment Services group, Xbox.
• Created standard operating procedure manuals for internal command center and off-shore supplier; Innovated internal operations manual to include a global focus. Managed external manual roll-out to Microsoft partners, Managed internal version for Microsoft Service Delivery Managers.
• Created timelines and reported on all phases of the content development lifecycle to all levels of stakeholder
Project Manager
Ivoxy Consulting-Kirkland, WA
October 2012 to November 2013
• Created contracts and budgets with account managers; scoped work and tracked tasks.
• Scheduled engineers for networking and storage implementation projects.
• Dispatched appropriate engineer to match client needs.
• Managed customer engagements from inception to completion of projects. Coordinated hardware moves and synced with customers daily to track progression.
• Project managed 10 consultants for scoping and envisioning of large-datacenter projects. Clients included ITron, Tableau, Charles Schwab, and World Vision.
• Oversaw logistics of networking equipment for disaster recovery sites moving from one part of world to U.S. and vice-versa.
Copy Writer
Wild Tangent-Redmond, WA
July 2012 to October 2012
• Wrote game copy for both PC and Android mobile devices.
• Employed search engine optimization techniques to drive website traffic. Genres included puzzle, time management, adventure, word games, and multiplayer online role-playing.
• Corresponded with main designer for marketing launch pages for seasonal campaigns.
• Worked with customer service for user issues and wrote corresponding help topics.
• Wrote blog copy.
Producer and Writer/Project Manager
Murphy & Associates-Kirkland, WA
September 2009 to March 2012
• Oversaw web production and delivery of house ads on the Xbox Dashboard.
• Managed subscriptions and strategies for different customer segments.
• Explored future business goals by observing testing environments and prototyping user experiences.
• Collaborated across teams; strategized findings from meetings and stakeholder discussions.
• Created images and other collateral with the Design, Marketing, and Development teams to enhance navigation and customer preferences, including development of UX elements.
• Supported and improved navigation for customer channels. Writer, project manager
• Wrote and researched product information for Microsoft Store Online (store.microsoft.com).
• Wrote style guide for international partner and participated in global planning, implementation, and content coordination.
• Liaised with business groups to acquire appropriate source material.
• Managed content workflow and produced content for hand-off to localization.
• Redesigned content for site refresh.
• Coordinated legal reviews; liaised with customer support to create help topics for Microsoft Store Online.
• Built relationships with business groups, creative director, legal, copywriters, and design staff to problem solve content issues and mitigate risks on special projects.
• Aligned with International Program Director to transition content from generic module-based approach to a more organic look and feel.
• Served as liaison with International reseller of record to manage content hand-off process.
• Key liaison to UX, merchandising, catalog manager, content, web production, and user acceptance testing (UAT) on migration project from proprietary server-based catalog to global website. Technical Editor
Microsoft-Redmond, WA
June 2008 to September 2010
• Oversaw development and management of editorial strategizing for help and support of Microsoft Windows 7.
• Managed team of writers; managed editorial calendar, schedule, resourcing, and workflow tasks.
• Edited screencasts and other supplementary video content.
• Partnered with writers for Windows Media Player, Windows Media Center, and Find andOrganize features.
• Led style decisions and acted in videos.
• Cross-collaborated with Marketing, User Research, and Windows Online Web teams.
• Produced content for hand-off to localization and was key spokesperson for localization house communications.
Managing Editor, Project Manager
Safeco Insurance-Seattle, WA
July 2007 to June 2008
• Prioritized and edited all training content for the Safeco University, which is the Safeco sales and customer support training division.
• Established editorial workflow into larger development workflow for 17 Instructional Designers.
• Managed and designed online application to automate editorial intake and workflow process.
• Condensed five style guides into one compiled file and updated product-specific team style guides.
• Worked with Project Managers from five departmental schools (organizational pillars) and assessed documentation for risk language.
• Managed a team of contract writers and editors.
Education
Certificate in Technical Editing
Bellevue Community College - Bellevue, WA
Vocational training in Clinical Research Professional Pima Community College - Tucson, AZ
Bachelor of Arts in Journalism
State University of New York - New Paltz, NY
Skills
• Ability to turn complex information into concise, comprehensible documents and articles
• Exceptional marketing writing and social media communication skills
• Organizational skills
• Adaptable and innovative mindset, committed to driving new workflows and managing change effectively
• NIST Standards
• Exceptional collaboration and interpersonal skills, ensuring seamless collaboration among stakeholders
• Proven expertise in writing, editing, and program/project management with demonstrated ability to manage and execute programs in a deadline-driven environment
• Innovate by using best practices, style guides and other collateral for marketing and technical communications
• Management
• Proficient in various writing, editing, and production tools, including Microsoft and open source/SaaS software to include maintaining shared documents in various systems Certifications and Licenses
E-RYT 500 (Experienced Registered Yoga Teacher) Yoga Alliance Present
First-Aid and CPR Certified Philadelphia Insurance Training in NAMI National Education Programs, Family Support Facilitator National Alliance on Mental Illness (NAMI)
Certified in ICH Good Clinical Practices (GCP)
Certified Nursing Assistant (CNA) Arizona
Security B Clearance, U.S. Government
Additional Information
Clinical Research Professional Certification, Pima Community College, 24 credit hours, site coordination and trial implementation, data management and informatics, product development and regulatory
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