Visionary. Focused on Results.
Services
Medical Writing & Scientific Editing
Review, rewrite, and refinement of peer-reviewed manuscripts, clinical evaluation reports, regulatory submissions, white papers, and scientific exchange materials. Ensuring accuracy, AMA-style compliance, and publication readiness at every stage.
Editorial Workflow Development
Design and implementation of end-to-end editorial processes for medical affairs and publications teams — from intake to MLR review to final output. Built to reduce turnaround time, improve consistency, and scale with your organization.
Publication Development & Review
Support for manuscript development, abstract preparation, textbook contributions, and KOL-authored content. Experienced with MLR review processes and regulatory compliance requirements across pharmaceutical and medical device sectors.
Medical Affairs Consulting
Strategic support for field medical teams, KOL engagement programs, and advisory board content. Includes process development, content standards, and documentation quality improvement.
Clinical & Regulatory Documentation
Preparation and review of clinical evaluation reports, risk assessments, FMEAs, complaint trend analyses, and compliance documentation for medical device and pharmaceutical clients.
Training & Instructional Content
Development of clinical training modules, instructional guides, and educational curricula grounded in adult learning principles. Designed for healthcare professionals, field teams, and regulated industries.
About Cynthia Lacker
I am a Registered Nurse with a Master of Science in Organizational Development and certification in Healthcare Risk Management (CPHRM). My career spans medical affairs leadership at Mallinckrodt Pharmaceuticals, product safety at DePuy Synthes and Siemens Healthcare, and patient safety research at ECRI Institute — before founding Lacker & Associates in 2023.
At Mallinckrodt, I served as National Director of both the Field Medical and Clinical Specialist teams — building editorial workflows that reduced publication turnaround by 66%, expanding KOL engagement by 40%, and improving field medical reporting capacity by 75%.
Today I work directly with pharmaceutical, medical device, and healthcare clients who need senior-level medical writing, editorial oversight, and publication strategy — without the overhead of a full-time hire.
I am also principal medical editor of the Allergy Immunotherapy Compendium, a veterinary dermatology textbook, and a published author of peer-reviewed articles across multiple clinical disciplines.