frank bottone

Formerly SRA International: Performed quality control (QC), revised for sponsor template, and assisted in the writing of sections of various CSRs (gabapentin enacarbil, Xenoport; rosuvastatin [2 Phase III CSRs], AstraZeneca).

Head medical writer charged with managing the planning, development and timely submission of conference abstracts, slide decks, and manuscripts while managing author input and regulatory/legal/marketing approval, as part of a highly productive group of health economics and outcomes researchers dedicated to a key client.

Lead medical writer on multi-functional team devoted to developing five interactive, multimedia medical education pharmaceutical sales training modules in the area of oncology.

Laboratory manager and molecular biologist for diverse research group studying the biology and chemopreventive effects of cyclooxygenase/lipoxygenase enzymes, prostaglandins and their regulation by NSAIDs, PPAR-gamma ligands and dietary compounds utilizing various molecular biology techniques.

Lead medical writer assigned to author, edit, and submit for regulatory approval 8 complex CSPs (Phases II-III) and supporting documents (Informed Consent Forms (ICFs), and standard operating procedures [SOPs]) for genomics-driven oncology clinical trials to support regulatory approval of various in vitro diagnostic devices. Managed document review and regulatory submission process for core facility devoted to managing oncology clinical trials (everolimus, panitumumab, and dasatinib) according to state, local, and federal FDA guidelines.

* IQVIA (formerly Quintiles): * Assisted lead writers in the production of complex regulatory medical writing documents (2 Integrated Summary of Safety/Efficacy, 2 CSRs, 1 IB, 1 CSP) for various clients in accordiance with GCP, FDA, and ICH guidelines. * Wrote patient narratives, summaries, adverse event reports, and patient discontinuations. * Under minimal supervision, critically evaluated, analyzed, and interpreted the medical literature to select primary resource materials ensuring adequate study design, scientific rigor, and absence of bias in materials written. * Authored post marketing evaluation summary Section 5.3.6 of a NDA for a new indication.

Primarily in oncology, member of a cross-functional project team accountable for the delivery of a wide-variety of regulatory documents on time and within budget/scope of work while exceeding client expectations Lead medical writer for complex regulatory documents (Phase II-III) such as clinical study protocols (CSP), clinical study reports (CSR), safety updates, sections of new drug applications (NDAs), Informed Consent Forms (ICFs), and Investigator Brochures (IBs) for FDA and EMEA submission of documents under the purview of good clinical practices (GCPs) and good laboratory practices (GLPs). Serve as client’s primary point of contact for medical writing, leading projects from kickoff to completion. Participate in project management and business development activities to develop, and win new business.