>20 years experience in medical writing working on scientific, clinical, and regulatory documents (eg, dozens of protocols, CSRs, IBs, manuscripts, posters) for a variety of indications. I have worked on 20 eCTD submissions and managed the medical writing team on most of these submissions. As a scientist (PhD biochemistry), I have hands-on experience in drug discovery research, nonclinical research, clinical development, medical affairs, drug information, quality assurance, and safety compliance. Let me know if we can help you with the writing of your regulatory, clinical, or scientific documents.Specialties: eCTDs (NDAs, BLAs, MAAs, INDs), CSRs (phase 1-3), IBs, protocols (phase 1-4), patient narratives, FDA briefing documents, FDA advisory committee presentations, posters, manuscripts, scientific presentations, competitive intelligence, white papers, marketing materials, grants, patents.
Listed skills include Manuscripts, Grants, Posters, White Papers, and 20 others.