Clinical Research Writing Lead & Evidence Strategist

Can you please provide a 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.

What does the team make-up look like – how many members and what is the break-down of the team’s skill sets (ex: 1 PM, 4 Developers, etc.)? I have 4 team members with mixed tenured scientific backgrounds. Across the team we have strong medical writing, biostats, medical research, and decades of industry experience.

What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)

• 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.

• 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

• How many rounds? 2-3
• Video vs. phone? Mix as needed