MDR - Sr Prin Clinical Research Spec; CER Writer

The CER-OMA team supports our clinical-regulatory filings for all pre‑market and post‑market technologies across all geographies and supports our global medical affairs operations with real‑time scientific use‑case assessments and dissemination.

We have four members with mixed scientific backgrounds, including medical writing, biostatistics, medical research, and decades of industry experience.

• Lead the authoring and critical review of scientific and clinical evaluation documents.
• Analyze complex clinical data into clear, accurate, and defensible written summaries.
• Ensure documents are scientifically sound and consistent.
• Function as a recognized independent SME who can influence decisions.
• Provide strategic clinical input to internal teams and leadership.
• Represent Clinical in cross‑functional planning and help the organization understand the clinical implications of decisions.

• Exceptional medical writing experience.
• Deep clinical research and clinical evidence development experience.
• Expert‑level ability to write, edit, and finalize documents.
• Ability to connect scientific evidence to regulatory, commercial, and clinical needs.
• Exceptional medical writing and scientific communication.

• Foundational cardiac knowledge and experience with electrophysiology procedures/technology.

• How many rounds? 2‑3.
• Video versus phone? Mix as needed.