Curriculum Vitae

Angela N. Johnson, MSE, PMP, RAC

I am a versatile Senior Manager of Clinical Affairs with experience in a range of therapeutic and diagnostic medical devices, pharmaceutical entities, and combination products. Combined bioengineering training and clinical trials experience enables me to tackle complex projects, generate quality documentation, and facilitate research strategy. I am an active member of national and international organizations, writing and speaking on clinical trial programs, public health, and innovations in health software and technology. I invite you to learn more about my experience  and to contact me.

 

Education

  • Doctorate of Philosophy in Technical Communication: Rhetoric of Science & HealthcareExpected 2018
    Texas Tech University (TTU), Lubbock, TX, USA
  • Master of Materials Science & EngineeringAwarded 2013
    North Carolina State University (NSCU), Raleigh, NC, USA
  • Post-Grad Chemistry Transfer ProgramCompleted 2010-2011
    University of North Carolina at Wilmington (UNCW), Wilmington, NC, USA
  • Bachelors of Fine Arts & Communications: TextilesAwarded 2006
    East Carolina University (ECU), Greenville, NC, USA

Professional Experience

Lead all operational functions to support clinical research programs with academic partners, including direct functional management of a team of 20+ biostatisticians, medical writers, data managers, project coordinators, and clinical research associates.

  • Implemented Oracle Cloud EDC system for Clinical Research
  • Lead development of SOPs
  • Participated in site CAPA processes
  • Conducted training and onboarding for functional team of 20+
  • Collaboratively developed vendor contracts with Contract Research Organizations and approved suppliers

Worked with global teams to develop and write clinical trial documentation for global multi-site clinical trials.

  • Collaboratively write and revise clinical study documentation (protocols/amendments, consents, reports, IBs, etc.) for diagnostic radiology, oncology, contrast/radiopharmaceutical, combination product studies
  • Generate reports, clinical summaries, and regulatory modules, in collaboration with regulatory affairs
  • Participate in research determination and research roadmap strategic planning operating mechanisms
  • Principal Writer for the GE-NFL Head Health Initiative mild traumatic brain injury (mTBI) trials and GE-Abbott biomarker collaboration, including participating in the GE-NFL Medical Advisory Board (MAB)
  • Manage writing assignments and professional growth opportunities (training/speaking) for junior writers
  • Engage directly with laboratory scientists and engineers to develop supporting documentation for complex products, chemical entities, and hardware/software, including investigator brochure and labeling
  • Lead interdisciplinary teams to develop new SOPs, generate new templates, implement document lifecycle planning, and address CAPAs for clinical trial templates/quality procedures in the US, China, and EU
  • Spearheaded implementation of the GE Global Clinical Writing Center of Excellence (COE) web portal and GE Investigator-Initiated Researcher Web Portal

Subject matter expert (SME) on protocols and documentation for external (US FDA, EU G-Med) audits

Wrote English-language clinical trial documents and revised Chinese-to-English protocol translations, regulatory submissions, and publication materials for Import and Local Manufacturing Devices (Classes I-III) and pharmaceutical trials (primarily domestic phase I-III, and international Phase IV trials).

  • Created English-language submissions for the Chinese State Food and Drug Administration Bureau (SFDA) and other international entities in Southeast Asia and North America, including the United States Food and Drug Administration (US FDA)
  • Worked with Chinese writers and investigators to produce CFDA regulatory submissions.
  • Worked extensively to write documentation for clinical trials through client projects, including Merck Sharp & Dohme (China) Ltd. (MSD), Sanofi-Aventis (China), Novo Nordisk Research Center (China), & others
  • Wrote documents for pharmaceutical and device research involving substantial bench and animal testing for reliability, dose testing, and biocompatibility
  • Create documents for CFDA High Risk and New Innovative products, ensuring that documents reflect Good Clinical Practice (GCP) requirements

Generated auxiliary materials in English to support clinical studies for medical devices, including MS PowerPoint slide decks, abstracts, posters, figures, and publications

Wrote a variety of documents to promote healthcare and higher education HIPAA-compliant internet technology solutions to enterprise-level clients, including pharmaceutical companies, major CROs, hospitals, physician franchises, state and local health departments, federal health programs, and community college systems.

  • Wrote client regulatory documents to fulfill US Food and Drug Administration (FDA) requirements  and requirements of Center for Devices and Radiological Health (CDRH) and state agencies, as needed
  • Wrote responses to Requests for Proposals (RFPs), vendor grants, and marketing subsidies, including annual Hewlett-Packard and Ingram-Micro healthcare and higher education grants
  • Provided regulatory documentation for a broad array of mid-sized medical device and healthcare clients, including US FDA 510(k) clearance and HIPAA-compliant electronic medical records (EMR) systems
  • Ensured complete documentation and version control during the document lifecycle
  • Provided training to junior members of the technical writing and marketing teams

Directed documentation and figure generation services supporting a broad array of mid-sized and enterprise-level clients, including medical, research, and healthcare organizations.

  • Worked directly with senior management and client investigators to write documentation on tight deadlines, often working on multiple projects with overlapping milestones
  • Ensured accurate translation of technical specifications to marketing materials
  • Worked to improve document tracking and revision system to shorten the time-to-deliverable completion

Worked in multi-lingual teams to design and construct industrial textile (sewn) solutions for well-known pharmaceutical, medical device, and other technology companies, including well-known Fortune 500 clients Pfizer, Zeiss, Toshiba, GE, Samsung, and others (e.g., VELCADE®/bortezomib) (Please note; Full-time from Sept 2006-Jan 2007).

Worked with engineering teams to construct and test industrial textile products

Provided product design specifications, tolerance drawings, manufacturing protocols, and packaging elements for a variety of industrial textile products for industry clients such as Pfizer, Corning, Glen Raven Mills, and others.

  • Wrote documents and generated preliminary CAD drawings to support manufacturing processes of industrial textile products, including significant work in textile-based medical and fiber-optics.

 

Academic/Instructional Experience

  • Part-time Cont. Education Instructor and Curriculum Designer2011-2013
    Texas Tech University (TTU), Coastal Carolina Community College
  • Graduate Teaching Assistant2010-2011
    University of North Carolina at Wilmington

Courses Taught

  • CE141 Introductory Photoshop – Introduces students to basic functions of photo editing and image manipulation in Adobe Photoshop. No previous Photoshop experience is required.
  • CE142 Intermediate Photoshop – Students will complete practical projects using basic functions, including photo editing and image manipulation. Students will be introduces to paths, vectors, levels, and working with color in Photoshop to take their skills to the next level. Previous completion of CE140 or equivalent Adobe Photoshop experience is required.
  • CE143 Photoshop for Small Business – Students will learn to use Photoshop for business applications, including developing professional identity through logos, business cards, and other visual media. We will also address practical applications such as how and where to affordably print or publish your materials. No previous Adobe Photoshop experience is required.
  • CE161 Introduction to Web Design – Introduces students to basic HTML, CSS, forms and templates for web design. Students will build a website as part of the course. No previous wed design experience is required.
  • CE162 Intermediate Web Design – Students will complete practical projects using HTML, CSS, and web design packages, including WordPress and its plugins. Students will create a functional website with advanced forms and features. Previous completion of CE161 or equivalent web design  experience is required.
  • CE163 Web Design for Small Business – Students work hands-on to learn basic web design and maintenance tools to create their own highly functional websites for small business using the WordPress Platform. We will also address practical applications such as how and where to affordably print or publish your materials. No previous Adobe Photoshop experience is required.
  • CE111 Introduction to MS Word – Students will learn to create documents by applying text, styles, and tables using Microsoft Word. No previous MS Word experience is required.
  • CHEM 101 Introductory Chemistry I (GTA)
  • CHEM 102 Introductory Chemistry II (GTA)
  • CHEM 201 Organic Chemistry I  (GTA)
  • CHEM 202 Organic Chemistry II (GTA)

Publications

Chapters

  • Johnson, A.N. (2017) “Medical Device Good Clinical Practice (GCP).” Introduction to FDA Regulation. Regulatory Affairs Professionals Society Publishing. [In Press]

Referred Presentations

  • Martin, R. Johnson, A.N. Regulation of 3D Printing and Algorithms. (RAPS 2017)
  • Johnson, A.N. Leading Medical Writing Teams [Round Table Panel) (AMWA 2017)
  • Wilson, E., Hebert, K.A., Turco, T.J., Johnson, A.N., Hersh, J.K. Direct and Indirect Costs Comparison of Cardiac Diagnostic Pathway in Coronary Artery Disease: CCTA as the Optimal Gateway to ICA [abstract]. Proceedings of the 2017 American College of Cardiology (ACC) Meeting. Washington, D.C.
  • Johnson, A.N., Murphy, S. Usability and Interoperability of Medical Device Software. (RAPS 2016)
  • Johnson, A.N. Collaborative Writing Toolkit: Results of a Survey of American Medical and Technical Writers in Health Care [Poster]. Annual Conference of the American Medical Writers Association (AMWA 2016)
  • Johnson, A.N. It’s Time for Medical Writers to Get Big and Dirty: Writing Opportunities in Data, Biometrics, and Technology. Annual Conference of the American Medical Writers Association (AMWA 2016)
  • Johnson, A.N., Cadogan, C., Lauer, C. Writing under Fire: Skills and Opportunities for Writing in a Crisis. Annual Conference of the American Medical Writers Association (AMWA 2016)
  • Johnson, A.N., Bippes B. Evidence and Power: Empowering research through mixed-methods in resource-limited, feasibility, and pilot studies. Annual Conference of the American Association for Bioethics and Humanities (ASBH 2016)
  • Johnson, A.N., Bippes B. Picking the “Good” Drugs: Empirical evidence for the role of physician morality in prescribing new medications [Pharmacy Ethics Session]. Annual Conference of the American Association for Bioethics and Humanities (ASBH 2016)
  • Johnson, A.N. Accuracy of Passive Magnetic Ultrasound Needle Guidance in High-Fidelity Conventional and Novel Simulated Block Approach Phantoms. Annual Conference of the American Association of Physicists in Medicine (AAPM 2016)
  • Johnson, A.N. Social Norms of “Good” Design: Interdisciplinary perspectives from a survey of engineers and clinicians in bioengineering. Annual Conference of the IEEE Engineering in Medicine and Biology Society (IEEE/EMBS 2016)
  • Johnson, A.N. Standards from the Start: A Practical Perspective on Strategic Use of CDISC Protocol Implementation Model 1.0. Clinical Data Interchange Standards Consortium (CDISC International Interchange 2015); http://www.cdisc.org/2015-International-Interchange
  • Johnson, A.N. Traumatic Brain Injury Patient Narratives in Social Media. Annual Conference of the American Society of Bioethics and Humanities (ASBH 2015)
  • Johnson, A.N. Social Media and Patient Communication: Writing and Research Strategies to Increase Online Impact [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2015); www.amwa.org/Files/Events/AC2015/2015RegistrationBrochure.pdf
  • Cadogan, C; Angela, A.N; Lauer, C. Transitioning Into Medical Writing for Diverse Professionals [Poster]. Annual Conference of the American Medical Writers Association (AMWA 2015); www.amwa.org/Files/Events/AC2015/2015RegistrationBrochure.pdf
  • Johnson, A.N. How To: A Practical Introduction to the Language and Rhetoric of Medical Device Software [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2014); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf
  • Johnson, A.N; Cadogan, C; Wang, X. From R&D to Clinical Trials: Medical Writing Strategies for Global Teams [Poster and Oral Presentation]. Annual Conference of the American Medical Writers Association (AMWA 2014); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf
  • Johnson, A.N. Hands-on Demonstration: Building and Growing Medical Writing Websites Using Open Source Content Management Systems (CMS) [Workshop]. Annual Conference of the American Medical Writers Association (AMWA 2013); www.amwa.org/files/events/ac2014/amwaregistrationbrochure2014.pdf

Editorial Experience

  • Medicine. Wolters Kluwer Health. Academic Editor and Manuscript Reviewer. (2012-Present)
  • Neurology. Reviewer. (2012-present)

Professional Service

  • Association of Clinical Research Professionals (ACRP), Educational Board Member (2015-16)
  • American Association of Physicists in Medicine (AAPM), Historical Board Member (2016-2017)
  • ISO/IEEE 11073 Personal Health Data (PHD) Interoperability Standards, Working Group Member (2015-2016)
  • GE-NFL Head Health Initiative, Medial Advisory Board Writer (2014-2016)
  • Association for Clinical Research (ACRP), Co-Chair Educational Committee, Greater Chicago Area (2015-2016)
  • Texas Tech University Humanities Center, Synoptics Wordscape Project (2015)
  • American Medical Writers Association (AMWA), Online Resources/Web Development Committee (2014-2015)
  • American Medical Writers Association (AMWA), Online Community/Web Development Committee (2013-2014)

Funding and Fellowships

  • Regulatory Affairs Convergence Faculty Speaker Honorarium ($500) | 2016, Regulatory Affairs Professionals Society (RAPS), San Jose, CA
  • GE Health Analytics Hackathon (Cardiac CAD in R) 1st place ($500) | 2016, Science and Technology Week, GE Healthcare, Waukesha, WI
  • GE makerPOSSIBLE: Laser Cut Bridge Challenge (“The Art of Biomechanics”) – 1st place in Artistry category ($250) | 2016, Science and Technology Week, GE Healthcare, Waukesha, WI
  • Employee Tuition Fellowship ($7,500/yr, 4 years) | 2013-18, GE Healthcare, Waukesha, WI
  • Ralph W. Brauer Fellowship (awarded in Nuclear Magnetic Resonance Spectroscopy and Proteomics; $1300) | 2010, University of North Carolina Wilmington, Wilmington, NC
  • East Carolina Academic Merit Fellowship ($20,000) | 2003, East Carolina University, Greenville, NC

Certifications

  • Regulatory Affairs Certification (RAC-US) | Active 2015 – Present | Regulatory Affairs professionals Association (RAPS)
  • Project Management Professional (PMP) | Active 2012 – Present | Project Management Institute (PMI)
  • Design and Interpretation of Clinical Trials | Completed 2016 | Johns Hopkins University, Baltimore, MD
  • Six Sigma Green Belt course | Completed 2016 | GE Crotonville, Healthcare Institute (HCI), Watertown, WI
  • Operations Management | Completed 2016 | University of Illinois, Urbana-Champaign, IL
  • Private Equity and Venture Capital Management | Completed 2015 | Università Bocconi, Italy
  • High Speed Project Management Certificate | Completed 2013 | University of Wisconsin, Madison, WI
  • Project Management Certificate | Completed 2008 | Cape Fear Community College, Wilmington, NC

Community Service

  • Insight! Milwaukee (2016). Volunteered in health career coaching for K9-12.
  • Jubilant Kid’s Foundation of Kenya (2015-2016). Volunteered creating technology resources and fundraising (http://www.jubilantkidsfoundation.org/)
  • GE-United Way Charity Drive, Milwaukee, WI (2013-2016). Volunteered in organizing online resources for charity drive.
  • Volunteer ASVAB Tutor (Mathematics/Physics) through CL Community Services, Wilmington, NC (2011-2012)
  • Tilestone Clinic, Wilmington, NC – Pharmaceutical Patient Advocate (2009-2011). Volunteered in preparing applications for chronic medication assistance to pharmaceutical companies on behalf of low-income patients

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