Head of Medical Writing, responsible for all aspects of the medical writing group, including authoring/oversight of document deliverables, vendors/contractors, processes, tools, etc.Worked collaboratively with several cross-functional groups to author key documents, including protocol amendments, meeting requests, briefing books, and other documents for regulatory submission. Also worked cross-functionally to refine medical writing process for document development, review, and finalization.

Responsible for leading and managing all efforts in writing and coordinating the completion of clinical study protocols and amendments, clinical study reports, and other regulatory documents, including agency briefing packages, Module 2 clinical summaries for marketing applications, and others. Expected to provide leadership within Medical Writing and work closely with cross-functional teams to ensure all documents are of high quality, completed on time, and compliant with all SOPs and regulatory guidelines. Additionally, responsible for establishing and implementing best practices and process for the development, review, and completion of clinical documents.

Responsible for leading the development and delivery of high-quality written documents to clients in a timely manner, including NDA, ANDA, BLA, and IND summary sections; CSRs; protocols; and other regulatory documents across many therapeutic areas. Provide objective and unbiased strategic insight to clients and offer relevant perspective related to drug class and or marketplace. Work with internal colleagues and external clients to develop and execute content-related components of projects.Also responsible for assisting with the development of SOPs, proposals, resourcing, performance reviews/development plans, recruiting, and training.

Responsible for the delivery of high-quality written documents to clients in a timely manner, including NDA, ANDA, BLA, and IND summary sections; CSRs; protocols; and other regulatory documents across many therapeutic areas. Provide objective and unbiased strategic insight to clients and offer relevant perspective related to drug class and or marketplace. Work with internal colleagues and external clients to develop and execute content-related components of projects. Assist with the development of SOPs, proposals, resourcing, performance reviews/development plans, and training.

Write and review clinical study reports and clinical study protocols for phase 1 and phase 2 clinical studies.

Project focused on the characterization of prion protein trafficking in primary neurons and astrocytes. • Design and conduct experiments using primary culture of mouse neurons and astrocytes as a model system. Requires coordination with animal care providers and writing animal research protocols. NIH-ACUC certified.• Examine the trafficking of fluorescently tagged purified prion protein in primary neurons, primary astrocytes, and co-culture using microfluidic chamber devices and confocal microscopy.• Evaluate potential mechanisms of prion spread and the ability of primary cells to maintain prion infectivity.• Develop manuscripts and present findings within the department and at conferences.

Studied the roles of Caveolin-1 and ErbB2 in the development and progression of diabetic peripheral neuropathy.• Designed and conducted experiments using wild-type, transgenic, and knockout mice as model systems.• Assessed mouse peripheral nervous system function via the Hargreaves method, the Von Frey method, the Randall-Selitto method, and electrophysiologically. • Examined the expression and activation of Caveolin-1 and the ErbB2 receptor using biochemical and microscopic techniques. • Analyzed data and interpreted results using appropriate statistical methods.• Developed manuscripts and presented findings within the department, School of Pharmacy symposia, and at international conferences.• Trained, assisted, and mentored junior graduate students and undergraduate students. Assisted with the management of the lab and acted as a liaison for IACUC and university compliance meetings.