Principal and Founder
Strategic and dedicated medical writing leader with broad expertise across diverse medical writing and clinical trial transparency and disclosure projects, workflow standards optimization, and program and portfolio team management. Proven success delivering key clinical regulatory documents, driving life-saving therapeutics to patients. Known for navigating teams and key stakeholders through evolving global regulations to communicate clinical trial information through compliant, responsible, and transparent frameworks. Fosters company culture and dedicated to integrity, efficiency, teamwork, and performance excellence.
Investigational New Drug (IND) Application | New Drug Application (NDA) |
Biologics License Application (BLA) | Marketing Authorization Application (MAA) | Abbreviated New Drug Application (ANDA) | Global Clinical Trial Transparency Protocol | Process Standardization and Compliance | Medical Writing & Communication | Employee Mentorship | Cross-Functional Program and Portfolio Team Management | Health Literacy Communication | Public Speaking | Strategic Planning | US & Global Regulatory Affairs | Health Canada PRCI & EMA Policy 0043 and Policy 0070 Secondary Publication Submissions | Regulatory & Clinical Medical Writing Document Development & Submission Strategy
First-in-Human (FIH) Protocol | Investigator’s Brochure | Development Safety Update Report | Informed Consent Form | Pharmacy Manual | eCTD Modules 2 & 5 | Clinical Study Report | Patient Narratives | Protocol Amendment | Layperson & Plain Language Summaries | Journal Manuscript | Conference Abstract & Presentation
SharePoint | Veeva RIM & Quality | EndNote | MedDRA | PleaseReview | WHO Primary Registries
TrialScope Disclose | CORE Reference | Common Protocol Template (CPT) |
Clinical Content & Reuse (CC&R) | ChatGPT
We listen to our clients and are flexible because every product and program is unique. Regmarole, LLC empowers clients and supports them in making the best decisions to bring products to market and significantly impact patient care.
We have qualified medical writing and clinical trial transparency experience working with large pharmaceutical companies and smaller biotechnology start-up companies, in therapeutic areas including oncology, hematology, dermatology, and neuro-degenerative and autoimmune diseases, as well as preventative areas like vaccines.
With a proven track record of success in the pharmaceutical and biotechnology industry, Regmarole LLC brings valuable insights and can quickly adapt to the work environment.
Drove mRNA platform expansion, launched 2 new global clinical trials for infectious disease vaccines.
Spearheaded IND applications for 2 flagship therapeutics treating chronic virology and infections, oncology, and serious diseases.
Led large-scale implementation of patient safety, privacy measures, and proprietary information protections.
Regmarole, LLC delivers exceptional service as measured by consistent work quality, commitment to finding the best solutions to address complex scientific questions, and timeliness in all areas of medical writing and clinical trial transparency deliverables.