About

With more than 14 years of experience in medical research and writing, I am well-versed in clinical and laboratory research, protocol design, regulatory documentation, statistical analysis, and scientific publications. 

Whether your target audience be academics or laypeople, I write for the reader… and for the format! My work includes journal manuscripts, conference posters and abstracts, slide decks, articles, surveys, blog posts, regulatory submissions, and oral presentations. Moreover, by working with many wonderful groups and projects, I am well-versed in a variety of therapeutic areas. My written work and expertise spans orthopedics,  wound healing, neurology, cardiovascular disease, genomics, immune response, metabolics, imaging, and more.

In addition to medical writing, I bring hands-on experience with various stages of  pharmaceutical and medical device technologies. From new product development, protocol designs, clinical evaluations, data analyses, regulatory submissions, risk management, marketing releases… I am a true cross-functional collaborator, with experience in almost every part of the product lifecycle.

As an avid learner and communicator, I also serve as a multi-tiered liaison for investigators and teams. Be it data interpretation, regulatory support, software assistance, or integrating contributors–I am ready to help. Whether you are clinical investigator or large corporation, my institutional and independent experience make me an adaptable team member and collaborator. And for every deliverable, my project management strategies balance high quality output with timely delivery.

Most importantly: I am committed to communicating the work of my clients, and I cannot wait to help you with your next project!

Verathon, Seattle, WA [Hybrid]
Clinical Affairs Specialist, 2023 (Present) 

Clinical Affairs Specialist and Medical Writer for Regulatory Submissions (EU MDD/MDR, FDA, TGA, HC, etc.), Marketing Releases, Product Launches, Post Market Surveillance Reporting, and more.

• Medical writing, editing, review, and research for development, maintenance, and support of global regulatory submissions (FDA, EU MDR, HC, TGA, etc.).
• Strategic direction for research and development, clinical trial design, execution, data collection, and evidence review.
• Clinical and regulatory guidance for cross-functional teams and projects, including documentation, publications, and marketing materials.
• Study development, strategy, and documentation support, including: CIPs, protocols, CRFs, Informed Consent Forms, presentations, etc.
• Development of EU MDD and MDR Clinical Evidence Plans and Reports (CEPs and CERs), including: planning, scoping, systematic searches and literature reviews, evidence review and extrapolation, state of the art review (areas of application, device backgrounds, and data analyses), comparative analyses and summaries of device performance, benefits, and safety, conformity analyses, and evaluation conclusions.
• Updates and development of SOPs, tools, and templates for CEP & CER development, in accordance with active and evolving EU Regulations and Guidances (MEDDEV, MDD, MDR, MDCGs).
• Periodic systematic literature reviews for product portfolio and maintenance of active bibliography.
• Post-Market Clinical Follow-up plans and strategies.
• Support for Periodic Safety Update Reports (PSURs) and post-market reports.

Zimmer Biomet (Later ZimVie), Westiminster, CO [Remote]
Senior Medical Writer, 2021 – 2023

Lead medical writer for Clinical Affairs (CA) for spinal medical devices, overseeing Clinical Evaluation Reports (CERs) development for all EU Medical Devices. Led six medical writers and worked with cross-functional teams to ensure accuracy, timeliness, and strategic alignment.

• Developed, drafted, and reviewed MDD & MDR Clinical Evaluation Reports (CERs).
  • Executed systematic searches to collect, review, aggregate, analyze, evaluate, and summarize clinical performance, benefits, and safety data for medical devices.
  • Worked on 20+ CERs over 2+ years (primary author and/or coordinated, developed strategy, served as subject matter expert, edited, and reviewed for submission).
  • Managed six writers for excess CEPs/CERs (including strategy, editing, & review).
  • Mentored and taught for intern program for CER development.
• Project Management for cross-functional teamwork, coordination, and alignment.
  • Developed critical websites, tools, and platforms for clinical and cross-functional inputs and interdependencies, interactive CER reviews, and timely submissions.
  • Reviewed, edited, and supported strategic/writing alignment between CER, PMCF, Regulatory, and other department documents.
  • Aligned SOPs/CER Schedule with correct EU Requirements, saving ~$300k/year.
  • Introduced/trained teams in collaborative, synced reference management system.
• Drafted reviews, standard operating procedures (SOPs), templates, work instructions.
• Represented CA with internal/external parties (e.g., HCPs, CER/PMCF NB responses).
• Drafted Regulatory Documentation inputs (e.g., clinical/performance/safety inputs for Instructions for Use (IFUs), Risk Management Reports, and Technical Documentation).
• Drafted and reviewed public materials (e.g., Marketing and Regulatory Documents).

Science in Writing, Portland, OR
Scientific Writing & Research Consultant, 2016 – 2023

Consulting for biomedical writing & editing (pharmaceuticals and medical devices, regulatory writing, research protocols, grants, marketing materials, abstracts and posters, manuscripts, lay publications, etc.). Worked with companies and primary investigators to support research, development, publications, and communications of findings. Work included:

• Developing and supporting regulatory and marketing documents.
• Collaborating with investigators in clinical and basic medical research.
• Supporting protocol design and writing, data management, & statistical analyses.
• Drafting study reviews, summaries, and/or reports (including regulatory documents, journal publications, abstracts, conference presentations, web publications, etc.).
• Analyzing data and interpreting results (biostatistics; bioinformatics; data visualization).
• Evaluating and selecting appropriate study measures and statistical models.
• Project management support for investigators and cross-functional teams.
• Reviewing and editing content and providing constructive feedback.

Armis Biopharma, Ft. Collins, CO [Hybrid]
Medical and Protocol Writer (Research Associate), 2013 – 2018

Medical research writing services, including: protocols, experimental design, statistical analyses, standard procedures, templates, regulatory documentation (e.g., FDA), publications, etc.

• Wrote wound research protocols for pharmaceuticals, antiseptics, and medical devices (for basic, translational, and clinical research).

• • Subjects included: topical and internal interventions, antiseptics, medical device applications (collagen gels, meshes, device coatings, and extracellular matrix scaffolds), and mechanisms of healing (e.g., genetic pathway analyses).

• Managed protocol projects and schedules for collaborative research (coordinating with researchers, supervisors, health care providers, external collaborators, etc.).
• Wrote and edited publications and internal regulatory documents (e.g., abstracts, posters, manuscripts, infographics, grant applications, literature reviews, study summaries, CSRs, CRFs, SOWs, SOPs, templates, manuals, and IRB proposals).
• Selected and/or developed and validated study measures for research protocols.
• Coordinated data collection and prepared statistical analyses (Excel, SPSS, R, etc.).
• Served as acting internal lab manager and administrator.

Vaccine and Gene Therapy Institute (OHSU), Beaverton, OR 
Research Technician, 2009 – 2010

Executed vaccine development and biomedical research for disease interventions at various stages for long-term, multitiered projects (including Cardiovascular Disease, HIV, and Chikungunya). Research activities included: bench science, data preparation, management, analyses, preparing/reviewing literature reviews, IRBs, and grant applications.

• Prepared viral vectors for altered genes, via single point mutations and bacterial plasmid growth/extraction, for use in vaccine development and efficacy research (working and coordinating outputs for basic and translational research).
• Reviewed/updated procedures (e.g., identified and rectified costly template error).
• Managed cell lines and migration assays for chemotaxis research.
• Instructed incoming students in laboratory protocols and procedures.

Brigham Young University, Provo, UT 
Multiple Research Assistant Positions: Dr. Brown, Dr. Allen, & Dr. Key

• Assisted multiple professors with study proposals, protocols, measure development, statistical analyses, literature reviews, and manuscript drafting/editing.
• Drafted and submitted regulatory proposals (IRB proposals).
• Prepared my thesis under Dr. Allen & Dr. Brown: A Meta-Analysis of the Effects of Stimulant Medications on Height and Weight for Children and Adolescents with ADHD

Bachelor of Science (BSc) in Psychology [Neuropsychology/Pre-Med Track]

BRIGHAM YOUNG UNIVERSITY
Graduated Cum Laude [3.92 GPA]

Publications

Jones IK, Burg JM, Haese NN, Andoh TF, Chambers AM, et al. Blocking the IL-1 receptor reduces cardiac transplant ischemia and reperfusion injury and mitigates CMV-accelerated chronic rejection. American Journal of Transplantation. 2021: 21(1):44-59

Prince A, Depenweiller M, Kumru B, Ahring KK, Chambers AM, Moseley K., “Proof of Concept N-of-1 Trial to Assess Strict Diet-LNAA Combination Therapy in Adult PKU” [Abstract]. In: GMDI: The Changing Landscape of Metabolics; April 30 – May 2; 2020 Austin, TX

A. Prince, M. Depenweiller, B. Kumru, K.K. Ahring, A. Chambers, K. Moseley, “Proof of Concept N-of-1 Trial to Assess Strict Diet-LNAA Combination Therapy in Adult PKU” [Abstract and Presentation]. In: 42^nd Annual Meeting of Society for Inherited Metabolic Disorders; April 26-29, 2020; Austin, TX

Neas, ED, Dunn, JA, Silva, ED, Chambers, AM, Luckasen, GJ, & Jaskowiak, A “Peroxy Pyruvic Acid-Containing Topical Anti-Infective: A Potential Candidate for a Wound Instillation Solution.” Advances in wound care 5.10 (2016): 432-443.

Neas E, Chambers Am. Prevalence of antibiotic resistance and potential suitability of a new antimicrobial for wound treatment. [Poster/Presentation F-232] In: Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). San Diego, CA. September17–21, 2015; September 17–21, 2015; San Diego, CA

Solo Presentations

MS Planner and SharePoint Presentation, “Planning and Executing Interactive Cross-Functional CER Reviews & Inputs”, interdepartmental presentation for ZimVie Spine, July 2022

Zotero Workshop, “Reference Management with Zotero”, interdepartmental and interdivisional presentations for Zimmer Biomet, November 2021 & January 2022

Excel Workshop, “Advanced Excel,” Skill-Building Workshop for Oregon Program Evaluators Network, April 22, 2019.

Pathway Analysis Review, “Pathway Analysis and Considerations,” OHSU Biostatistics Core, March, 15, 2019.

Full Academic Scholarship, Brigham Young University                               2007-2012
Awarded for outstanding academic performance

Dean’s List, Brigham Young University                                                        2009-2010
Recognition for outstanding academic achievement

English Merit Award, High School
Awarded for top writing performance in graduating class