Content Writer

• Serve as a subject matter expert; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies.
• Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
• Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
• Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
• Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy, relevance and to ensure that medical communications objectives are met.
• Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
• Manage the development and execution of a “rolling” strategic publication plan for clinical and real-world evidence (RWE) studies, ensuring alignment with the medical and clinical development strategy and adhering to industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc.).
• Lead the development, review, editorial, approval, and submission of manuscripts, abstracts, posters, and presentations across clinical trials, real-world evidence studies, and health economics outcomes research (HEOR).

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