• Developed strategy and wrote clear and concise clinical documents, including clinical study reports, investigator’s brochures, subject narratives, and regulatory submission documents• Collaboratively prepared for an advisory committee meeting• Actively contributed to briefing documents, response documents, and pediatric investigational plans• Actively supported clinical project teams, representing medical writing and took responsibility for timely and accurate medical writing deliverables, negotiating timelines as necessary• Managed the writing and completion of documents and other assigned tasks within established timelines (editing, quality control [technical editing], and publishing activities) and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes• Contributed to statistical output plan concerning organization and table layout for a specific document• Provided strategic direction to the clinical project team relative to consistency of key messages across documents within a project and regulatory requirements/guidance for submission documents• Ensured that medical writing activities were coordinated between the project team and management of the medical writing group• Served as the medical writing subject matter expert for multiple company integrations• Led and participated in multiple process improvement initiatives, including standard operating procedure updates.

• Anticipated, identified, and solved problems, including process, resource, and team dynamics issues• Managed individual projects and clients by monitoring budget, timeline, and resources• Ensured appropriate resourcing for all projects at the start of each project and at each document milestone• Managed work flow for a 24-hour, international company within and across project teams• Maintained a working knowledge of all active projects• Created scopes of work for prospective projects and clients• Maintained training records for all employees

• Managed, wrote, formatted, and edited clinical study reports, subject narratives, and investigator’s brochure updates• Assisted with a summary of clinical safety, summary of clinical efficacy, clinical overview, and periodic safety update report• Wrote literature summaries• Compiled reference lists for summary documents• Created, managed, and tracked a document library for an New Drug Application• Quality control reviewed multiple types of documents• Managed document teams• Maintained a working knowledge of multiple client’s style guides and templates

• Wrote, edited, and formatted subject narratives to be submitted with a Biologics Licensing Application• Quality control reviewed protocols and clinical study reports• Shadowed clinical team meetings