Curriculum Vitae

 

Professional Experience

SVP Advisory Services — Avania Clinical | Boston, MA (2025–Present)

Strategic oversight and P&L ownership for advisory services division encompassing regulatory strategy, cybersecurity, R&D engineering and product development, product compliance, market access and reimbursement, and AI/SaMD consulting across medical devices, diagnostics, cell and gene therapies, and device/drug-led combination products.

• Regulatory, Compliance & Market Access Leadership: Manages a team serving 450+ medtech and biotech customers developing innovative FDA, EU MDR/EMA, and globally regulated medical products.
• Hardware/Software Product Development & Engineering Leadership: Oversight of Toronto Design Lab with end-to-end medical device cybersecurity capabilities (SBOM management, threat modeling, penetration/fuzz testing, vulnerability assessment against CISA KEV, and Section 524B premarket documentation). Full compliance infrastructure for AAMI TIR57 security risk management. Additional capabilities include IEC 60601 testing, human factors engineering, and software V&V for cardiovascular, neuromodulation, and digital health technologies.
• Strategic Transformation: Expanding Advisory Services from compliance-focused consulting to premium technology-enabled strategic advisory. Building specialized practices in PCCP strategy, adaptive algorithm validation, EU AI Act compliance, and digital therapeutics regulatory pathways.
• Team Building: Establishing a team of senior principals to create specialized expertise in AI/SaMD, EU MDR Notified Body processes, and FDA breakthrough device pathways. Driving operational improvements including Salesforce HealthCloud modernization and service delivery optimization.

 

Senior Managing Director, Global Regulatory & Compliance — Cytiva (a Danaher Company) | Boston, MA (2023–2025)

Led global regulatory and compliance staff and technology systems for a top-10 life sciences technology company, overseeing 100+ global professionals across product compliance, customer services, and lifecycle development and delivery of production compliance cloud software to over 100,000 users across Americas, Europe, APAC, and global regions.

• Technology & Systems Leadership: Owned enterprise Salesforce (SFDC) and Product Lifecycle Management system regulatory compliance architecture, high-impact organizational infrastructure supporting sales operations and customer-facing high-volume compliance document requests. Led software development team for proprietary data lake and customer-facing API delivering change control, compliance, and CAD engineering integration. Directed AI/software rollout for technical writing and R&D teams, including electronic batch records implementation.
• Compliance & Cybersecurity: Oversight of medical device regulatory compliance for cybersecurity and organizational systems security. Global product and facility compliance across 40+ countries. Medical device regulatory team (MDR/IVDR, 510(k), global registrations).

 

Global Head of Regulatory Strategy — Roivant Sciences | Boston, MA (2021–2023)

Led regulatory due diligence and strategic analysis for health tech and biopharma asset acquisitions, managing financial analysts and regulatory strategy teams supporting in-licensing decisions across Roivant’s portfolio of subsidiary companies.

• Deep expertise in buy-side and sell-side biopharma M&A, including data room operations with Pfizer, Takeda, J&J, Teva, and academic partners
• Deep expertise in buy-side and sell-side health tech ventures, ranging from AI-driven chemistry synthesis to next-generation compliance systems cloud software deployment at production global scale
• Financial analysis and regulatory program planning for FDA-regulated therapeutic portfolios
• Supported intake and strategic development of active medical technologies across multiple “vant” subsidiaries

 

Senior Director, Regulatory Affairs & Global Head — Sigilon Therapeutics (Flagship Pioneering) | Cambridge, MA (2019–2021)

As Head of Regulatory Affairs for Flagship-backed Sigilon Therapeutics, acted as strategic and operational lead to rapidly implement agile regulatory compliance and technology operations in fast-paced start-up environment, leading to successful FDA, EMA/CA, and ANVISA designations and IND/CTA filings for first-in-class genetically engineered cell therapy tissue product, as well as ISO 13485 companion medical device codevelopment.

• Provided inputs to Series B funding, regulatory strategy, and departmental oversight with direct responsibility to top executives
• Oversaw regulatory team, eCTD publishing team, and vendor services
• Authored primary IND documents, Orphan Drug Designations (ODD), and PRIME/Fast-track designations
• Advised on ISO 10993 and medical device compliance for combination products, cell scaffolding, and cell therapy components

 

Director, Regulatory Strategic Development & Market Access — IQVIA | Raleigh, NC (2018–2019)

Led launch of IQVIA MedTech’s strategic advisory functions during M&A integration of Novella Clinical. Drove multimillion-dollar strategic business development in medtech pipeline with oversight of regulatory and data science teams.

• Built integrated medtech advisory practice during critical organizational transformation
• Led 30+ member global regulatory team through M&A integration
• Established strategic partnerships driving revenue growth in medical device and diagnostics segments
• Oversaw IT integrations to enable integrated global data and trial offerings on the IQVIA MedTech platform

 

Associate Director, Regulatory & Scientific Affairs — CTI Clinical | Cincinnati, OH (2017–2018)

Led dynamic early-phase regulatory projects for medtech and combination products, including novel oncology products and cell, gene, and tissue engineered therapeutics. Participated in and led multidisciplinary consulting project teams in gene, cell, and rare disease therapy products. Served as scientific/regulatory resource for business development, advisory boards, and client engagement across drug development and HECOR-related projects.

 

Senior Manager, Clinical Affairs Operations — GE Healthcare, Global Research Organization | Milwaukee, WI (2013–2017)

Led a 50+ person global organization spanning data science and biostatistics, clinical operations, field clinical services, and medical/technical writing, responsible for clinical validation of 200+ medical device studies annually across 41 countries with direct oversight of US, EU, and China-based teams.

• Clinical Trials and Imaging Systems Algorithm Validation: Led clinical V&V for synthetically reconstructed MRI systems (MAGiC), earning first FDA, EU, and China NMPA clearances and the AJNR Lucien Levy Award for the landmark multicenter prospective trial. Directed validation of AI-driven passive magnetic ultrasound needle guidance technology (published in Regional Anesthesia & Pain Medicine). Managed clinical testing development for the GE-NFL-DoD Head Health Initiative ($60M four-year collaboration on traumatic brain injury imaging).
• Enterprise Clinical Data Systems & Data Infrastructure Management: Led implementation of Oracle Health Sciences clinical trial platform. Operationalized QMS and lean improvements driving cost and time efficiencies across portfolios. Directed development of proprietary operational software for clinical trial acceleration.
• Portfolio Impact: Supported FDA IDE/510(k)/PMA and IND/BLA/NDA clearances across MRI, PET/CT, ultrasound, blood pressure monitoring, and EEG/waveform technologies spanning GE’s global imaging and radiotracer portfolio as well as GE Ventures.

 

Principal Medical Writer, Electrically Active Products — MedSci Healthcare (Bioon Group 生物谷)

Shanghai, China (2010–2013)

Led global medical/technical documentation teams, supporting 400+ clinical trials across US, EU, and APAC regions, with specialization in software and electronically active medical devices. Wrote premarket clinical trial protocols, reports, and publications for device and pharmaceutical clients including Zeiss, GE, Merck Sharp & Dohme (MSD), Sanofi-Aventis, and Novo Nordisk Research Center.

 

Senior Project Manager (IT Security) — EiS Technologies | Wilmington, NC (2000–2010)

Led onsite enterprise IT security, server infrastructure, network architecture, and compliance systems installations and upgrades, including enterprise Healthcare/HIPAA, university and college systems, and DoD-compliant installations. Hands-on technical foundation spanning hardware installation, system administration, and security architecture built over a decade in locally-owned technology services firm. Liaised with public health organizations and CROs including PPD and Quintiles. Administered QMS ISO 9001, 21 CFR Part 11, PCI, HIPAA, and US FDA compliance.

 

Director, Manufacturing Technologies — Queensboro.com | Wilmington, NC (2007–2008)

Led digital transformation of large-scale textile manufacturing operation during industry transition from silk-screen to digital printing. Owned CAD infrastructure, IT systems, and electronic embroidery technology implementation. Full technical ownership of digital printing and graphics systems across manufacturing operations.

 

CAD & Technical Writing Leader — Parrott, Inc. | Greenville, NC (2003–2006)

Designed and implemented enterprise CAD/CAM manufacturing infrastructure, transitioning legacy paper-based pattern systems to Lectra digital platform. Built foundational manufacturing technology systems for textile production operations.

 

Academic & Instructional Experience

Professor of Strategic Development & Regulatory Affairs — Northeastern University, College of Professional Studies | Boston, MA (2021–Present)

• Faculty member teaching FDA regulatory strategy in the Regulatory Affairs master’s program.

Associate Faculty — Coastal Carolina Community College | Jacksonville, NC (2011–2013)

• Taught enterprise web development including custom PHP programming, database integration, and scalable CMS deployment for production environments. Also served as continuing education instructor and curriculum designer.

Education

Doctor of Philosophy (PhD), Technical Communication — Concentration: Rhetoric of Science & Healthcare
Texas Tech University (TTU), Lubbock, TX

Master of Science (MS), Materials Science & Engineering
North Carolina State University (NCSU), Raleigh, NC

Post-Baccalaureate Studies, Chemistry
University of North Carolina at Wilmington (UNCW), Wilmington, NC

Bachelor of Fine Arts (BFA), Fine Arts & Communications
East Carolina University (ECU), Greenville, NC

 

Courses Taught

Northeastern University, Boston, MA:

• RGA 6463 — Regulatory Strategy Throughout the Lifecycle

Coastal Carolina College, Jacksonville, NC:

• CE 141/142/143 — Introductory Graphic Design for Business and Medical Professionals
• CE 111 — Introduction to Document Design for Medical and Science Professionals

 

Publications

Book Chapters

• Parks, A., Butt, N., Farcas, S., & Johnson, A. N. (2026). Regulatory strategy for digital therapeutics and artificial intelligence-enabled devices. In ICLG – Digital Health Laws and Regulations 2026 (Chapter 5). Global Legal Group. https://iclg.com/practice-areas/digital-health-laws-and-regulations
• Johnson, A. N. (2019). Regulating cell & gene therapies, genetically modified cells and devices in regenerative medicine. In US Regulatory Affairs Fundamentals (11th ed.). Regulatory Affairs Professionals Society (RAPS).
• Johnson, A. N. (2017). Medical device clinical testing and GCPs. In US Regulatory Affairs Fundamentals (10th ed.). Regulatory Affairs Professionals Society (RAPS).

Peer-Reviewed Journal Articles & Conference Abstracts

• Johnson, A. N., Fulgoni, A., Wang, L., Racordon-Pape, S., & Almgren, M. (2023). Quantifying challenges to development of generics and biosimilars in non-Hodgkin’s lymphoma therapeutics: The future of low-cost alternatives from monoclonal antibodies to CAR-T [Abstract 5148]. Blood, 142(Supplement 1). Presented at the 65th American Society of Hematology Annual Meeting, San Diego, CA. https://ash.confex.com/ash/2023/webprogram/Paper187818.html
• Johnson, A. N. (2021). A look at FDA’s gene and cell therapy framework launch in 2020, and its impact on new hemophilia treatments in 2021 and beyond. Dateline Federation: Emerging Therapies Special Issue, 22(1), 7. https://www.hemophiliafed.org/dateline/
• Johnson, A. N. (2020). An ethnographic pilot study of decision-making among non-research physicians. Molecular Therapy, 24(No. 7, Supplement 1), 157.
• Johnson, A. N. (2020). Public engagement in novel gene therapies for hemophilia and blood disorders: A computational analysis of public sentiments in social media. Molecular Therapy, 24(No. 7, Supplement 1), 158.
• Johnson, A. N. (2019). Determinants of patient response to clinical trial recruitment advertisements in gene therapy: A pilot ethnographic study and trend-over-time simulation model. Molecular Therapy, 27(No. 4, Supplement 1), 157.
• Qi, W., Davis, H. W., Chu, Z., Vallabhapurapu, S. D., Hussain, N., Franco, R. S., Morris, J. C., Johnson, A. N., & Olowokure, O. O. (2018). Combined effect of gemcitabine (GEM) and sapC-DOPS nanovesicles on pancreatic ductal adenocarcinoma (PDAC) in mice. Journal of Clinical Oncology, 36(Supplement). ASCO Annual Meeting Proceedings.
• Cruze, C. A., Rixe, O., Morris, J. C., Puduvalli, V. K., Villano, J. L., Wise-Draper, T. M., Johnson, A. N., & Wesolowski, R. (2018). Allometric scaling of preclinical pharmacokinetic and toxicokinetic parameters to predict clinical pharmacokinetics of BXQ-350 saposin C protein-phosphatidylserine nanovesicles. Journal of Clinical Oncology, 36(Supplement). ASCO Annual Meeting Proceedings.
• Cruze, C. A., Rixe, O., Morris, J. C., Puduvalli, V. K., Villano, J. L., Wise-Draper, T. M., Johnson, A. N., & Wesolowski, R. (2018). Absence of indicators of hypercoagulability and antiphospholipid syndrome in BXQ-350 first-in-human study. Journal of Clinical Oncology, 36(Supplement). ASCO Annual Meeting Proceedings.
• Rixe, O., Morris, J. C., Puduvalli, V. K., Villano, J. L., Wise-Draper, T. M., Muller, C., Johnson, A. N., Wesolowski, R., & Qi, X. (2018). First-in-human, first-in-class phase 1a study of BXQ-350 for solid tumors and gliomas. Journal of Clinical Oncology, 36(Supplement). ASCO Annual Meeting Proceedings.
• Johnson, A. N. (2018). Virtual and augmented reality as game-changers in anesthesiology: History, applications, and challenges for clinical virtuality. Journal of Anesthesia & Intensive Care Medicine, 5(1), 555652. https://juniperpublishers.com/jaicm/JAICM.MS.ID.555652.php
• Hassan, A. E., Sanchez, C., & Johnson, A. N. (2017). Endovascular treatment outcomes using the Stroke Triage Education, Procedure Standardization, and Technology (STEPS-T) program. Interventional Neuroradiology, 24(1), 91–96. https://pubmed.ncbi.nlm.nih.gov/29119876/
• Tanenbaum, L., Tsiouris, A. J., Johnson, A. N., Naidich, T. P., DeLano, M. C., Melhem, E., Quarterman, P., Parameswaran, S. X., Shankaranarayanan, A., Goyen, M., & Field, A. (2017). Synthetic MRI for clinical neuroimaging: Results of the MAGnetic resonance Image Compilation (MAGiC) prospective, randomized multicenter, multireader trial. American Journal of Neuroradiology, 38(6), 1103–1110. http://www.ajnr.org/content/early/2017/04/27/ajnr.A5227
• Johnson, A. N., Peiffer, J. S., Halmann, N., Delaney, L., Owen, C. A., & Hersh, J. (2017). Ultrasound-guided needle technique accuracy: Prospective comparison of passive magnetic tracking versus unassisted echogenic needle localization. Regional Anesthesia and Pain Medicine, 42(2), 1–10. https://journals.lww.com/rapm/
• Johnson, A. N. (2017). Harmonization of gene therapy regulation. Regulatory Focus. Regulatory Affairs Professionals Society.
• Johnson, A. N. (2017). Small organizations, big regulatory strategy. Regulatory Focus. Regulatory Affairs Professionals Society. http://www.raps.org/Regulatory-Focus/
• Johnson, A. N., Lauer, C., & Cadogan, C. (2016). How did you get here? Stories of bench research, Bollywood, and stormy epiphanies. AMWA Journal, 33(3), 118–119.
• Johnson, A. N. (2016). Social norms of “good” design: Interdisciplinary perspectives from a survey of engineers and clinicians in bioengineering. Proceedings of the 2016 IEEE 38th Annual International Conference of the Engineering in Medicine and Biology Society (EMBC), Orlando, FL, 4337–4340. http://ieeexplore.ieee.org/document/7591687/
• Johnson, A. N. (2016). Perception and implementation of collaborative documentation technologies among medical physics educators and industry professionals: A current practice survey. Medical Physics, 43, 3355. https://doi.org/10.1118/1.4955697
• Johnson, A. N. (2016). Accuracy of passive magnetic ultrasound needle guidance in high-fidelity conventional and novel simulated block approach phantoms. Medical Physics, 43, 3461. https://doi.org/10.1118/1.4956135

 

Refereed Presentations

• Johnson, A. N. (2025, June 16). Regulatory acceleration & innovation: Leveraging new policies for a smarter biopharma go-to-market strategy [Panel presentation]. BIO International Convention, Boston, MA.
• Johnson, A. N. (2024, September 18). Accelerating novel platforms into the clinic: Early experiences with FDA’s Advanced Manufacturing Technology (AMT) designation and global perspectives [Conference presentation]. Regulatory Affairs Professionals Society (RAPS) Annual Conference, Salt Lake City, UT.
• Nurbo, J., & Johnson, A. N. (2024, May). Comparative interrater analysis of regulatory challenges in recently approved gene therapies for sickle cell disease: Towards a semi-quantitative method for assessing gene therapy regulatory development complexity [Poster presentation]. American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting.
• Wang, L., & Johnson, A. N. (2024, May). Systematic analysis of primary field data from biologics therapy regulatory non-approvals: Why aren’t we talking about FDA rejections [Oral presentation]. American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting.
• Johnson, A. N. (2024, May). Comparative analysis of sterile grade filters in adeno-associated virus (AAV) manufacturing: Accelerating first-in-human AAV therapeutic production with quality by design principles [Oral presentation]. American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting.
• Abate, E., White, G., Kassim, S., Sivlotti, M., Westberg, M., & Johnson, A. N. (2024, May). Deliver what’s next: Fueling the future of autologous CAR-T therapy [Conference presentation]. International Society for Cell & Gene Therapy (ISCT) Annual Meeting.
• Wang, L., & Johnson, A. N. (2025, May). Strategies and technologies for advanced CMC [Oral presentation]. International Society for Cell & Gene Therapy (ISCT) Annual Meeting.
• Johnson, A. N., & Zahora, J. (2021, November). Working through contract research organization (CRO) issues to stay in control of your study [Panel presentation]. Outsourcing Clinical Trials New England.
• Johnson, A. N. (2021, May). Ethnographic social world and actor-network analysis of the gene therapy commercialization landscape [Poster presentation]. American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting.
• Johnson, A. N. (2021, March). Optimizing regulatory strategy for gene therapies: Current trends, guidance and industry milestones [Conference presentation]. Gene Therapy for Rare Blood Disorders Conference, Boston, MA.
• Johnson, A. N. (2020, June). Drug-device combination treatments and diagnostics [Roundtable session]. Proventa International CMC Regulatory Affairs Summit.
• Johnson, A. N. (2020, May). Public engagement in novel gene therapies for hemophilia and blood disorders: A computational analysis of public sentiments in social media [Poster presentation]. American Society of Gene & Cell Therapy (ASGCT) 23rd Annual Meeting.
• Johnson, A. N. (2020, May). Prescribing gene therapy: An ethnographic pilot study of decision-making among non-research physicians [Poster presentation]. American Society of Gene & Cell Therapy (ASGCT) 23rd Annual Meeting.
• Johnson, A. N. (2020, March). Gaining insights into a successful hemophilia gene therapy trial [Conference presentation]. Gene Therapy for Rare Blood Disorders Conference, Boston, MA.
• Johnson, A. N. (2020, March). Strategic gene therapy product platforms and partnerships: From codevelopment to companion products [Workshop]. Gene Therapy for Rare Blood Disorders Conference, Boston, MA.
• Johnson, A. N. (2019). Determinants of patient response to clinical trial recruitment advertisements in gene therapy: A pilot ethnographic study and trend-over-time simulation model [Conference presentation]. American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, Washington, DC.
• Johnson, A. N. (2019). Introducing agile in regulated industries: Leading agile in MedTech [Conference presentation]. TriAgile, Raleigh, NC.
• Johnson, A. N. (2018). Accelerating innovative device strategy: From modernizing the 510(k) to improving the de novo [Conference presentation]. Regulatory Affairs Professionals Society (RAPS) Convergence, Philadelphia, PA.
• Johnson, A. N. (2018). If you can write a grant, you can write a pitch deck [Conference presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N. (2018). Leaping from desk to podium: Essential presentation skills for medical writers [Conference presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N. (2018). Human gene editing and advanced therapies: How will FDA, EMA, and gene therapy mix? [Conference presentation]. Regulatory Affairs Professionals Society (RAPS) Convergence, Vancouver, BC.
• Johnson, A. N. (2018). The gap between clinician-led cell therapy evidence and marketed products: A quasi-experimental comparative pilot study of young venture clinical development [Poster presentation]. American Society of Gene & Cell Therapy (ASGCT) Annual Conference.
• Rixe, O., Morris, J. C., Puduvalli, V. K., Villano, J. L., Wise-Draper, T. M., Muller, C., Johnson, A. N., Wesolowski, R., & Qi, X. (2018). First-in-human, first-in-class phase 1a study of BXQ-350 for solid tumors and gliomas [Poster discussion panel]. American Society of Clinical Oncology (ASCO) Annual Meeting.
• Johnson, A. N. (2017). Explore the global medical writing movement and emerging career growth opportunities [Conference presentation]. CBI Medical Writing Summit, Philadelphia, PA.
• Martin, R., & Johnson, A. N. (2017). From additive to algorithm [Medical device session]. Regulatory Affairs Professionals Society (RAPS) Convergence, Washington, DC.
• Johnson, A. N. (2017). Mentoring and growing medical writing teams [Roundtable panel]. American Medical Writers Association (AMWA) Annual Conference.
• Wilson, E., Hebert, K. A., Turco, T. J., Johnson, A. N., & Hersh, J. K. (2017). Direct and indirect costs comparison of cardiac diagnostic pathway in coronary artery disease: CCTA as the optimal gateway to ICA [Abstract]. American College of Cardiology (ACC) Annual Meeting, Washington, DC.
• Johnson, A. N., & Murphy, S. (2016). Usability and interoperability of medical device software [Conference presentation]. Regulatory Affairs Professionals Society (RAPS) Convergence, San Jose, CA.
• Johnson, A. N. (2016). Collaborative writing toolkit: Results of a survey of American medical and technical writers in health care [Poster presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N. (2016). It’s time for medical writers to get big and dirty: Writing opportunities in data, biometrics, and technology [Conference presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N., Cadogan, C., & Lauer, C. (2016). Writing under fire: Skills and opportunities for writing in a crisis [Conference presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N., & Bippes, B. (2016). Evidence and power: Empowering research through mixed-methods in resource-limited, feasibility, and pilot studies [Conference presentation]. American Association for Bioethics and Humanities (ASBH) Annual Conference.
• Johnson, A. N., & Bippes, B. (2016). Picking the “good” drugs: Empirical evidence for the role of physician morality in prescribing new medications [Pharmacy ethics session]. American Association for Bioethics and Humanities (ASBH) Annual Conference.
• Johnson, A. N. (2016). Accuracy of passive magnetic ultrasound needle guidance in high-fidelity conventional and novel simulated block approach phantoms [Conference presentation]. American Association of Physicists in Medicine (AAPM) Annual Conference.
• Johnson, A. N. (2016). Social norms of “good” design: Interdisciplinary perspectives from a survey of engineers and clinicians in bioengineering [Conference presentation]. IEEE Engineering in Medicine and Biology Society (IEEE/EMBS) Annual Conference, Orlando, FL.
• Johnson, A. N. (2015). Standards from the start: A practical perspective on strategic use of CDISC Protocol Implementation Model 1.0 [Conference presentation]. CDISC International Interchange.
• Johnson, A. N. (2015). Traumatic brain injury patient narratives in social media [Conference presentation]. American Society of Bioethics and Humanities (ASBH) Annual Conference.
• Johnson, A. N. (2015). Social media and patient communication: Writing and research strategies to increase online impact [Poster and oral presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Cadogan, C., Johnson, A. N., & Lauer, C. (2015). Transitioning into medical writing for diverse professionals [Poster presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N. (2014). How to: A practical introduction to the language and rhetoric of medical device software [Poster and oral presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N., Cadogan, C., & Wang, X. (2014). From R&D to clinical trials: Medical writing strategies for global teams [Poster and oral presentation]. American Medical Writers Association (AMWA) Annual Conference.
• Johnson, A. N. (2013). Building and growing medical writing websites using open source content management systems (CMS) [Workshop]. American Medical Writers Association (AMWA) Annual Conference.

 

Editorial Experience

• Medicine (Wolters Kluwer Health). Academic Editor and Manuscript Reviewer. 2012–Present.
• Molecular Therapy (Cell Press / ASGCT). Reviewer. 2017–Present.
• Neurology (AAN). Reviewer. 2012–Present.

 

Select Media & Press

• Cited in: Philippidis, A. (2025). “In-region, for region”: Cytiva builds out $1.6B in global expansion projects. GEN Edge, 7(1), 452–458. https://doi.org/10.1089/genedge.7.1.084
• Quoted in: Philippidis, A. (2025, June). Compliance head: “We need to keep that big picture” on drug development amid regulatory changes. GEN Edge. [Coverage of BIO International Convention panel presentation.]

 

Professional Service

• Co-Chair, Chemistry, Manufacturing, and Controls (CMC) Committee, American Society of Gene & Cell Therapy (ASGCT), 2025–Present
• CMC Manufacturing Panel Moderator, American Society of Gene & Cell Therapy (ASGCT), 2024
• Government Relations Committee Member, American Society of Gene & Cell Therapy (ASGCT), 2018–2022
• Board Member, Biotech Mentor, 2007–Present
• Contributing Member, American Society for Quality (ASQ), 2018–2020
• Educational Board Member, Association of Clinical Research Professionals (ACRP), 2015–2016
• Historical Board Member, American Association of Physicists in Medicine (AAPM), 2016–2017
• Working Group Member, ISO/IEEE 11073 Personal Health Data (PHD) Interoperability Standards, 2015–2016
• Medical Advisory Board Writer, GE-NFL Head Health Initiative, 2014–2016
• Co-Chair Educational Committee (Greater Chicago Area), Association for Clinical Research (ACRP), 2015–2016
• Synoptics Wordscape Project, Texas Tech University Humanities Center, 2015
• Online Resources/Web Development Committee, American Medical Writers Association (AMWA), 2013–2015

 

Certifications

• Regulatory Affairs Certification (RAC-US) | Active 2015–Present | Regulatory Affairs Professionals Society (RAPS)
• Certified GMP Professional (CPGP) | Active | International Society for Pharmaceutical Engineering (ISPE)
• Project Management Professional (PMP) | Active 2012–Present | Project Management Institute (PMI)
• Design and Interpretation of Clinical Trials | 2016 | Johns Hopkins University
• Six Sigma Green Belt | 2016 | GE Crotonville, Healthcare Institute (HCI)
• Operations Management | 2016 | University of Illinois, Urbana-Champaign
• Private Equity and Venture Capital Management | 2015 | Università Bocconi, Italy
• High Speed Project Management | 2013 | University of Wisconsin, Madison
• Project Management Certificate | 2008 | Cape Fear Community College

 

Funding & Awards

• Lucien Levy Award — Best Original Research Article | 2017, American Journal of Neuroradiology (AJNR)
• Regulatory Affairs Convergence Faculty Speaker Honorarium (Grant Awarded) | 2016, Regulatory Affairs Professionals Society (RAPS), San Jose, CA
• GE Health Analytics Hackathon — 1st Place, Cardiac CAD in R (Grant Awarded) | 2016, GE Healthcare Science & Technology Week
• GE makerPOSSIBLE: Laser Cut Bridge Challenge (“The Art of Biomechanics”) — 1st Place, Artistry (Grant Awarded) | 2016, GE Healthcare Science & Technology Week
• Employee Tuition Fellowship (4-Year Grant Awarded) | 2013–2018, GE Healthcare
• Ralph W. Brauer Fellowship in NMR Spectroscopy & Proteomics (1-Year Grant Awarded) | 2010, University of North Carolina Wilmington
• East Carolina Academic Merit Fellow (Scholarship Grant Awarded) | 2003, East Carolina University

 

Community & Nonprofit

• The Real Cat Labs (2024–Present). Founder. Nonprofit 501(c)(3) for furthering education in human-AI interactions. www.therealcat.ai
• Insight! Milwaukee (2016–2018). Volunteer Health Career Coach, K–12.
• Jubilant Kids Foundation of Kenya (2015–2016). Volunteer Fundraising Director.
• GE-United Way Charity Drive, Milwaukee, WI (2013–2016). Volunteer Community Event Coordinator.
• Volunteer ASVAB Tutor, Mathematics/Physics, Community Services, Wilmington, NC (2011–2012).
• Tilestone Clinic, Wilmington, NC (2009–2011). Patient Advocate — Prepared chronic medication assistance applications for low-income patients.