- 11 years in medical writing, specializing in medical/pharmaceutical/scientific drafting and editing.
Writing – Protocols, Investigator Brochures, Annual Reports, Investigational New Drug (IND) Application Sections, Marketing Applications, Briefing Documents, Regulatory Meeting Slide Decks, Publications, Clinical Study Reports; Document Formatting and QC; Project Management.
Proficient in International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and American Medical Association (AMA) style guidelines.
Independent Contract Medical Writer
Work with clients to complete clinical and regulatory projects across various indications (e.g., oncology, vaccines, medical device). Responsible for drafting and finalizing clinical study reports (CSRs), protocols, Investigator’s Brochures (IBs), annual reports, marketing applications, Investigational New Drug (IND) application sections, briefing documents, regulatory meeting slide decks, publications, and other documents/projects as well as formatting and performing document quality control (QC).
Senior Medical Writer, Array BioPharma, Inc.
Lead medical writer for clinical development projects across various indications including oncology and inflammation. Drafted and finalized CSRs, protocols, IBs, and briefing documents, and QCed other writers’ work.
- CSRs: Full CSRs for a Phase 3, randomized, placebo- and active-control study in chronic osteoarthritis and for a Phase 1 dose-escalation study in advanced cancers.
- IBs: Several oncology product IB updates.
- Briefing documents: FDA Type B meeting briefing package.
Senior Medical Writer, Allos Therapeutics, Inc.
Lead medical writer for global clinical and regulatory oncology projects (both solid tumor and lymphoma). Performed project management, drafting, and finalization of protocols, CSRs, IBs, annual reports, IND sections, marketing applications, briefing documents, regulatory meeting slide decks, and publications.
- US New Drug Application (NDA) electronic common technical document (eCTD) submission: interim/final CSRs, integrated summaries (CSS/CSE), 120‑day safety update, and slides for an Oncologic Drugs Advisory Committee (ODAC) meeting.
- European Marketing Authorisation Application (MAA) eCTD submission: interim/final CSRs, integrated summaries (CSS/CSE), Clinical Overview, EU Risk Management Plan, Pediatric Investigational Plan, Request for Maintenance of Orphan Drug Designation (ODD), Request for Conditional Approval, Day 120/180 Responses, Grounds for Re-examination, and slides for pre-MAA meetings, oral hearings, and scientific advice group (SAG) meetings.
- EU ODD: 2 successful applications for ODD (cutaneous T-cell and Hodgkin’s lymphomas) including briefing packages, response documents, and regulatory meeting slides, as well as annual reports for each designation.
- IND submission: pre-IND briefing package and all clinical documents for an initial IND.
- Special Protocol Assessment (SPA): study protocol and briefing document requesting SPA for a confirmatory trial mandated by accelerated approval.