Lancaster, New York, United States
Senior medical writer on clinical study or regulatory project teams for early phase through Phase 3 projects providing scientific/regulatory writing (CSRs, protocols, protocol amendments, ICFs, narratives) and technical expertise in the writing, production, and review of clinical/regulatory and scientific documents. Plans and coordinates report writing activities with staff to ensure completion of high quality writing projects. Mentors less experienced writers on complex projects as needed. Scientific and writing competence in several therapeutic areas including, immune disorders, oncology, diabetes, and cardiovascular and metabolic diseases (dyslipidemia, atherosclerosis, and hypertension). Experienced publications writer, preparing commercialization publications (manuscripts, review papers, slide sets, posters, and abstracts) for all clinical phases and health outcomes for submission to medical/scientific journals and scientific conferences. Previously a drug discovery and development pharmacologist with over 20 years of R&D experience in pharma, 2.5 years in the vascular medical device industry, and 5 years in academia (postdoc, instructor and research investigator levels) writing/editing manuscripts, grant proposals, posters, slide sets, oral presentations, patents, technical plans, research reports, IND pharmacology summaries. A proven track record managing direct reports (executing research, writing papers and reports, ensuring completion of performance goals and career development mentoring). Hands on experience leading projects and teams in drug discovery and development, and advancing drug candidates into clinical trials.
Responsibilities and Accomplishments • Senior medical writer on clinical study or regulatory project teams for early phase through phase 3 projects providing scientific/regulatory writing (CSRs, protocols, protocol amendments, ICFs, narratives) and technical expertise in the writing, production, and review of clinical/regulatory and scientific documents. • Plans and coordinates report writing activities with staff to ensure completion of high-quality writing projects • Scientific and writing competencies in several therapeutic areas including, immune diseases, oncology, diabetes, and cardio-metabolic diseases (lipid disorders, atherosclerosis and hypertension). • Provides project management support throughout the document life cycle, establishing relationships with authoring teams to ensure efficient delivery of high quality content. • Represents the medical writing department on clinical study teams and at meetings regarding the writing project. • Interacts with colleagues in data management, biostatistics, clinical pharmacology, pharmacokinetics, regulatory affairs, and medical affairs as necessary to produce high quality and timely writing deliverables. • Works effectively with clients and internal editing teams to complete quality reviews, approvals, submission, and production of published documents. • Experienced publications writer, preparing publications (manuscripts, review papers, slide sets, posters, and abstracts) for all clinical phases and health outcomes for submission to medical/scientific journals and scientific conferences. • Independently completed writing and publishing of several Phase 1 CSRs for a large Pharma partnership • Independently completed several Phase 1 protocols, protocol amendments and administrative letters for a large Pharma partnership
Responsibilities and Accomplishments • Provided scientific/regulatory guidance and technical expertise in the writing, production and review of clinical/regulatory and scientific documents. Planned and coordinated report writing activities with staff to ensure completion of high quality writing projects. • Independently developed and produced medical writing deliverables for clinical and regulatory documents: CSRs, protocols, protocol amendments, medical writing plans, narratives, ICFs, and commercial publication documents: manuscripts, abstracts, posters, oral presentations covering all phases of clinical research across several therapeutic areas. • Provided project management support throughout the document life cycle, establishing relationships with authoring teams to ensure efficient delivery of high quality content. 2018/2019: in addition to several manuscripts completed and published, completed CSRs, Protocols, ICFs and Narratives. Charleston Labs: Phase 2 CSR (Pain inhibitor product) Mereo Biopharma: 6 ICFs (master, pregnancy partner, genetic) Daiichi; 25 Narratives AstraZeneca: 7 ICFs Galecto Biotech: 4 ICFs Bayer: Protocol (topical dermatology product) Pieris Biopharma: MAD Protocol (asthma product) OncoMed: Phase 2 CSR, (oncology product) Ascend: Phase 1 CSR (wound healing product) Cell Medica: Phase 2 CSR (oncology product) Alderya: Phase 3 CSR (dermatology product) Intercept Pharma: Phase 1 CSR (NASH inhibitor) Lexicon: Phase 3 (30 narratives)
Publications writer responsible for preparing pharmaceutical commercialization publications (Phases 2/3, Phase 4/post-marketing, and health outcomes) for submission to medical/scientific journals and scientific conferences and congresses..
Investigated links between inflammation and vascular injury. Elucidating mechanisms of endothelial function/dysfunction in the context of vascular injury and consequences of NF-kB activation downstream of GPCRs.