About Us

Jennifer Houser

Principal and Founder

Medical Writing and Clinical Trial Transparency Professional

A Passion For Medical Writing

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.

"In medical writing, there is no danger in being too precise—only in being imprecise."

-Edith Schwager

"It's the core of collaborative, evidence-based, scientific inquiry. Transparency of results discovered fulfills our promise to protect the patients who rely on our medicines every day."

-Vic Ho

Leading The Way in Medical Writing

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

Why choose us?

Benefits of Regmarole, LLC

outstanding Performance

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.

Customer Service

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.

15+ years experience

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.

Our Achievements

Experience in the Industry

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.

01

/03

Moderna, Associate Director, Medical Writing

Drove mRNA platform expansion, launched 2 new global clinical trials for infectious disease vaccines.

Aug 2022 to Oct 2023

02

/03

Silverback Therapeutics, Director, Medical Writing

Spearheaded IND applications for 2 flagship therapeutics treating chronic virology and infections, oncology, and serious diseases.

Jan 2021 to Jul 2022

03

/03

Seagen Inc., Senior Manager Global Transparency & Clinical Trial Disclosure, Medical Writing

Led large-scale implementation of patient safety, privacy measures, and proprietary information protections.

May 2017 to Dec 2020