MDR - Sr Prin Clinical Research Spec

Title: MDR - Sr Prin Clinical Research Spec/ Sr. Prin. Clinical Research Scientist, for Clinical group of CAS

Contract Duration 12+Months

TECHNICAL SKILLS

Must Have

• CER and PER Medical Writer
• preparation of CER and TF

Nice To Have

• a clinical medical writer
• Ad-hoc CER Medical Writer

Summary of the project/initiative which describes what’s being done:

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

Top 5 responsibilities for this position:

• Lead the authoring and critical review 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.

Skills/attributes are a must have:

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

Skills/attributes are nice to have:

• Foundational cardiac knowledge and experience with electrophysiology procedures/technology