Senior Director of Medical Writing, OncologyGlobal Clinical Trial Operations

Director of Medical Writing, OncologyGlobal Clinical Trial Operations

•Responsible for the development and timely delivery of message-driven documents, including clinical summary documents, briefing documents, clinical trial reports, and various medical education and training materials. •Interface and collaborate with internal cross-functional groups, external thought leaders, and contract medical writers to deliver high-quality, accurate, concise documents to support regulatory agency review.•Contribute to development of global regulatory documentation strategy and execution of tactics.

•Head of Medical Writing for Genzyme's rare disease registries, overseeing the development of publications and regulatory documents. •Managed and trained contract medical writers and off-shore service providers. •Managed timelines and budgets. •Collaborated with internal project teams and external physicians to plan analyses and data presentation.•Provided leadership and project management skills to ensure high-quality documents were delivered on schedule•Ensured that publications were developed according to ICMJE and GPP guidelines. •Tracked publications and trained medical writers in the use of Datavision software.•Served as lead medical writer for project team; wrote various regulatory documents for submission in the US and EU (CSRs, protocols, annual reports, investigator brochures, BLA, MAA, etc). Wrote and edited manuscripts for publication in biomedical journals, as well as abstracts, posters, and slide decks. Established relationships with external and internal stakeholders.

Established online scientific and medical writing business. Managed a staff of PhD-level medical writers to write and edit manuscripts, research grant proposals, book chapters, and other technical materials for scientists and clinicians.

Received research funding from National Institutes of Health, (R01, NHLBI) and American Heart Association. Presented reserach at scientific conferences. Trained graduate students and laboratory staff and managed projects and budgets.

Awarded PRAT fellowship by the National Institute of General Medical Sciences to conduct diabetes-related basic research at the National Institute of Diabetes and Digestive and Kidney Disease, in the laboratory of Dr. Derek LeRoith.

Basic laboratory research on neurobiological mechanisms associated with substance abuse, in the laboratory of Dr. Eric Nestler.