Summary
Offer comprehensive medical writing, editing, reviewing, quality check, and formatting services for the biotechnology, pharmaceutical, medical device, and related industries. Recent projects: clinical protocols for oncology, cardiology, infectious disease, and CNS indications, and an sBLA.
Medical writing and editing: Provide clients with medical writing, reviewing, editing, and formatting services for regulatory documents and manuscripts. Regulatory document projects include regulatory submissions, including eCTDs (NDA, BLA, and sBLA) and INDs; clinical study protocols, amendments, clinical study reports (CSRs), and IBs; drug safety documentation, including serious adverse event (SAE) and adverse event (AE) narratives; process development and CMC reports; preclinical manuscripts; pharmacokinetic (PK) and toxicology reports; GXP audit reports; and informed consent forms. Perform QC and report findings for clinical, research, and process development/CMC documents. Draft, edit, and format manuscripts for publication in peer-reviewed journals; abstracts; posters; and slide sets. Prepare documents for publication, using Acrobat and ISIToolbox (cross-references, hyperlinks, bookmarks, and automatic Table of Contents). Use EDMS software (eg, LiveLink, Documentum).
Medical writing infrastructure: As needed, form and supervise medical writers for companies that need medical writing support. Develop medical writing infrastructure documents (eg, SOPs, guidelines, style guides, work practice documents, checklists, and Word and PowerPoint templates).
Technical, scientific, and other writing: Write technical documents for CMC and process sciences, including experimental design, data presentation, and data analysis. Draft and edit web content; work with programmers to optimize web site presentations. Draft, review, and edit press releases.
Management: If requested by clients, form medical or scientific writing teams (including medical writers, medical copy editors, and proofreaders), and direct writers’ work to ensure on-time and on-budget project completion.
Skills & Experience
Experienced in all phases of drug and biologic product development. PhD scientist with research training in medical microbiology, immunology, and human infectious diseases. performed laboratory research for 6 years. For the last 14 years, directed medical writing departments at five life-science companies. This experience in biotechnology and medical devices, combined with a strong publication record, demonstrates a rare combination of medical knowledge, analytical skills, and medical writing and editing expertise.
Clinical areas of writing expertise include oncology, cardiology, pediatric/adult neurology, infectious diseases, drug safety, and more. Examples: GBM, brain metastases, squamous cell carcinoma, NSCLC, atherosclerosis, CGD, Crohn’s disease, AMD, neutropenia, influenza, HBV infection, HIV/AIDS, CHF, CAD, GVHD, and artificial human organs.
Publications include numerous medical articles, abstracts, posters, a book chapter, web content, newsletters, patient education brochures, and more.
NOTE: OUR WRITING AND EDITING FEES VARY WITH EACHPROJECT. FEES ARE STRUCTURED ON A PER-HOUR BASIS, NOT BY THE PAGE OR BY THE PROJECT. PLEASE DISCUSS YOUR PROJECT WITH DR CALDWELL, AND YOU WILL RECEIVE A QUOTE FOR YOUR INDIVIDUAL PROJECT.