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.

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.
• 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.
• 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.
• 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).

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.
• 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.

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.
• 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.
• 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.
• 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.

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.

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.