Ash Chambers Email & Phone Number

Portland, Or, Us

United States

Providing Clinical Affairs strategic direction and support, cross-functional clinical and regulatory guidance, as well as medical writing and documentation services.- 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.- Medical writing, editing, review, and research for development, maintenance, and support of global regulatory submissions (FDA, EU MDR, HC, TGA, etc.).- 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.

Westminster, Colorado, United States

Lead medical writer for Clinical Affairs (CA) for spinal medical devices, overseeing Clinical Evaluation Reports (CERs) development and strategic alignment for all EU Medical Devices. Led six medical writers and worked with cross-functional teams to ensure accuracy, timeliness, and project alignment. (Zimmer Biomet Spine Inc. --> ZimVie)• Developed, drafted, and reviewed MDR Clinical Evaluation Reports (CERs). >> o Executed systematic searches to collect, review, aggregate, analyze, and evaluate all relevant clinical performance, benefits, and safety data for medical devices. >> o Managed several writers for additional CERs (including evaluation strategy and editing/reviews). >> o Introduced collaborative reference/document management platform; trained Spine and Dental writing divisions in use. >> o Mentored and taught for intern program for CER development. • Project Management for cross-functional collaboration, coordination, and alignment. >> o Developed critical websites, tools, document management systems, and platforms for clinical and cross-functional inputs and interdependencies, interactive CER reviews, and timely submissions. >> o Supported alignment between CER, PMCF, Regulatory, and R&D strategies.• Drafted reviews, standard operating procedures (SOPs), templates, and work instructions. • Represented Clinical Affairs for meetings with internal/external parties (e.g., HCPs).• 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).

Portland, Oregon Area

Consulting services for medical writing, regulatory writing, research design and protocols, and biomedical publications. I offer more than 14 years experience, services, and support for medical research writing, including:• Biomedical writing & editing (Clinical Evaluations (CERs), research protocols, grants, marketing material, abstracts and posters, manuscripts, lay publications, etc.).• Clinical Evaluation Reports (CERs) for Medical Devices in the EU Market.• Regulatory writing (e.g., public facing documents such as Instructions for Use (IFUs) or Technical Documentation).• Development and support for public regulatory and marketing documents.• Cross-functional teams coordination and project management.• Development/Drafting standardized procedures, templates, and work instructions.• Collaborating with investigators in clinical and basic medical research (such as: protocol design, data analysis, web publications, journal publications, etc.).• Developing protocols and procedures for investigative studies.• Analyzing data, interpreting results, and data presentation (biostatistics/bioinformatics; Figures and Graphs).• Evaluating and selecting appropriate study measures and applications.My dynamic and varied research support/experience ranges from orthopedics (medical devices), genetic pathway analysis, vaccine development, cardiovascular disease, neurobiological conditions, wound healing, and more. Please contact me with your project needs, and I will provide timeline estimates and information on availability. Thank you![Note: Availability is dependent upon concurrent engagement and/or limitations related to current work]

Fort Collins, Colorado Area

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). >>>o 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).• 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.).Company LinkedIn: https://www.linkedin.com/in/armis-biopharma-0633aa157/

Fort Collins, Colorado, United States

Medical research writing services, including: Experimental design, protocols, statistical analyses, standardized procedures, templates, and publications (writing, design, and data presentation). Primary responsibilities included: writing and research for chronic wounds, wound healing, and interventions, including: external and internal interventions, medical device applications, and mechanisms of action (e.g., genetic pathway analyses).Services ranged from: • Collaborating with researchers and health care providers to design & write research protocols, data collection procedures, and patient consent forms.• Writing protocols for clinical, translational, and basic research in wounds/antiseptics/medical device applications.• Writing & editing abstracts, manuscripts, grant applications, and internal and public communications materials (including infographics and presentations)• Creating standardized templates for protocols, request documents, and research manuals/guides.• Developing and/or selecting study measures/methodology.• Creating pharmaceutical and medical device application research procedures and protocols • Coordinating with researchers, supervisors, providers, health care providers, collaborators, etc.• Managing projects and schedule for collaborative research• Collecting and/or coordinating data collection and evaluating outcomes (providing statistical and visual analyses)• Standardizing laboratory policies and procedures (e.g., drafting SOPs and templates)• Acting lab manager/administrator

Provo, Utah, United States

Assisted multiple professors with writing and design for research studies, literature reviews, methodology and measure development, data collection, and regulatory proposals.Areas of application included:- Central Nervous System (neurology)- Impacts of ADHD treatments on growth and development- Judicial procedures

Executed vaccine development and biomedical research for disease interventions at various stages for long-term, multitiered projects (including Cardiovascular Disease, HIV, and Chikungunya). Responsibilities included:• Generated and analyzed research data• Laboratory activities, data preparation/management, and preparing/reviewing grant applications• Reviewed processes and procedures (e.g., identified and rectified costly template error).• Prepared materials and coordinated processes for translational research.• Performed data analyses and literature reviews. • Grew and maintained numerous cell lines (human, mammalian, and bacterial).• Performed cell migration assays for intervention responses.• Organized and cataloged cell cultures, assay records, and frozen inventories.• Executed several stages/tasks simultaneously (developing fine-tuned time management skills). • Assisted lab management and administration.

Portland, Oregon Area

Assembled and organized client records for secure storage and dated access. Assessed existing records' systems and revamped them to improve employee access and reduce search times.

Bachelor Of Science (B.Sc.), Psychology, Overall: 3.92; Major: 3.98

Activities and Societies: Research Assistant, Ice Hockey, Art Program, Activities Planner, Practicum, Tutoring, and Tutor Outreach.

Education record

Activities and Societies: National Honor Society, Student Body Publicist, Snowboard Team, Water Polo, Choir, Drama Club, Plays, Musicals.