Alexandra M. Sielaff
Summary
Experienced and knowledgeable Early Phase Clinical Medical Writer with over 10 years of expertise in pharmaceutical CRO research. Strong background in writing and editing early phase clinical reports and protocols for the pharmaceutical industry. Excels at delivering high-quality documents within strict time and budget constraints.
Overview
11
11
years of professional experience
Work History
Senior Medical Writer
ICON Clinical Research
01.2021 - Current
- Comprehensive knowledge of medical writing tasks and able to liaise with other functional groups as related to writing quality protocols, clinical study reports, and other related deliverables
- Facile with documents of high scientific complexity (ie, non-routine and/or complex protocols and reports in various study populations, with multiple objectives and endpoints)
- Peer review, as well as interpret, analyze, and present data from early phase clinical studies
- Write, review, edit, and QC documents for clients including synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, clinical development plans, and analysis plans that meet scientific and regulatory standards
- Lead discussions with clients regarding development of protocols and/or report analysis
- Participates in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping, and documentation, SOP authoring, review and revision, gap analysis, department training plans, style guides, templates, or procedures
- Mentors other medical writers, including training and supervision of workload for junior medical writers, as needed
Nonclinical Safety Pharmacologist
Covance/LabCorp
11.2015 - 01.2021
- Provided administrative and scientific support within the Safety Pharmacology business unit
- Responsibilities included set-up, collection, selection, and analysis of physiology study data working with surgically implanted telemetry models, as well as respiratory and central nervous systems
- Activities included pre-study tasks (i.e., protocol development, costing, and scheduling), post-surgical telemetry signal evaluation, monitoring the progress of assigned studies, interacting with clients, preparing report components (i.e., drafting progress reports, writing report procedures, and reviewing results and conclusions in final reports for accuracy) for FDA submissions
- Performed formal peer reviews of reports within the Safety Pharmacology unit
- Acted in a dual role as Safety Pharmacologist/ Nonclinical ECG Analyst for Safety Pharmacology studies conducted at Shanghai and Harrogate sites
- Addressed QA audits and client comments relating to protocols and reports and participated in client discussions on report findings
- Troubleshooted computer/data analysis system problems and resolved issues during set-up, collection, analysis, and transfer
- Mentor/trainer to new Safety Pharmacologists in the department
- Key trainer for foreign colleagues at Harrogate and Shanghai sites in respiratory and cardiovascular models
- Spent 6 weeks at Shanghai site setting up the core battery of Safety Pharmacology in vivo assays, training colleagues, installing equipment, developing and conducting validation studies in preparation for CFDA certification in Safety Pharmacology models
- Validated whole body plethysmography at Madison and Shanghai site
Nonclinical Electrocardiography Associate
Covance/Labcorp
01.2014 - 11.2015
- Reviewed and analyzed ECG recordings to appropriately measure waveform intervals
- Set up and operated computerized data acquisition and analysis systems to analyze ECGs collected from dogs, nonhuman primates, and pigs in toxicology and safety pharmacology studies
- Responsible for data organization, QA audit responses, internal and external client communication, and quality check procedures
- Monitored progress and status of time-sensitive documents to ensure internal and external clients receive study information within specified deadlines
- Recognized abnormal rhythms such as premature atrial, junctional, and ventricular contractions, atrial fibrillation, ventricular fibrillation, bigeminy, ventricular tachycardia, and more
Education
M.S. - Clinical Exercise Physiology
East Stroudsburg University
East Stroudsburg, PA01.2013
B.S. - Exercise Science and Sports Studies
Rutgers University
New Brunswick, NJ01.2010
Skills
- Clinical Trial Reports/Protocols
- Data Interpretation
- Proofreading
- Collaborative Teamwork
- Editing
- Critical Thinking
- ICH & GCP Guidelines
Community Service
- Therapy Dog Handler, Go Team Therapy Dogs, Knoxville, TN, 01/01/17, Current
Timeline
Senior Medical Writer
ICON Clinical Research
01.2021 - Current
Nonclinical Safety Pharmacologist
Covance/LabCorp
11.2015 - 01.2021
Nonclinical Electrocardiography Associate
Covance/Labcorp
01.2014 - 11.2015
M.S. - Clinical Exercise Physiology
East Stroudsburg University
B.S. - Exercise Science and Sports Studies
Rutgers University