Content Writer

• Lead day-to-day activities of medical writing team; train, coach, and monitor performance.
• Assist Director, Medical Writing with strategic planning, resource allocation, and standardizing policies for regulatory document drafting and finalization.
• Plan, manage, and prepare internal and external communications of scientific and clinical data including abstracts, posters, presentations, manuscripts, congress materials, and educational/training materials.
• Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments.
• Work closely with in-function and cross-functional teams on document strategies and regulatory submission strategies.
• Draft, edit, and finalize regulatory documents (protocols, IBs, CSRs) for FDA submission and global regulatory submissions.
• Develop and implement Scientific Communications SOPs and ensure publication activities align with strategic initiatives and industry best practices.
• Lead project team and document review meetings; provide direction and solutions to cross-functional teams on document content and expectations.
• Ensure quality, consistency, alignment, and compliance of regulatory documents and publications, including eCTD formatting and hyperlinking.
• Perform ad-hoc and cross-functional projects to support business needs and provide developmental opportunities.

Associate Director, Medical Writing

Specification Writer IV

Specification Writer III

Epic Report Writer, Cogito

Adjunct Instructor – The Teaching of Reading, Writing, and Language Arts in the Primary Grades

Part-time Merchandiser/Order Writer