Director, Medical Writing – Oncology (1999-2008); – Respiratory Inflammation and Autoimmune Disease; Cardiovascular and Metabolic Disease; and Vaccines (2009-2015); MedImmune (subsidiary of AstraZeneca), Gaithersburg, MarylandResponsibilities:  Directed Medical Writing function for designated therapeutic areas Supervised and mentored up to 6 in-house employees Managed third-party medical writing vendors Provided scientific and clinical input for protocol design, statistical and safety data analysis, and interpretation of study results Wrote/reviewed study protocols (and amendments), informed consents, Phase 1-3 clinical study reports (CSRs), briefing documents, investigator brochures (IBs), investigational medicinal product dossiers (IMPDs), Orphan Drug Applications, patient safety narratives, clinical summaries for Investigational New Drug (IND) submissions and Annual Reports, clinical sections of the Common Technical Document (CTD), as well as draft manuscripts, abstracts, and posters; worked in Documentum-based environment Actively participated in cross-functional team meetings Developed/maintained Standard Operating Procedures (SOPs), Work Practice Documents, and document templates (protocol, IB, and CSR) Maintained strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines  Supported clinical trial transparency initiative by managing redaction of submission documents and posting of clinical trials results on public-accessible web sites (clinicaltrials.gov; EudraCT).

Supervised Medical Writing function via training and coordination of in-house and contract medical writersPrepared and reviewed both clinical and preclinical documentation including CSRs, NDAs, IBs, and Product Monographs Analyzed statistical findings for data tabulations and summariesPrepared meeting abstracts, slide templates, peer-reviewed journal manuscriptsReviewed case report forms (CRFs)

Organized and prepared Phase 1-4 CSRs, integrated summaries of safety and efficacy, human pharmacokinetics and bioavailability summaries, and clinical pharmacology summaries as required by worldwide regulatory agencies for NDAs, INDs, and post-marketing surveillance studies. Participated in project team meetingsAnalyzed statistical and safety dataPrepared draft journal manuscripts and graphic presentations for posters and slides.