MDR - Sr Prin Clinical Research Spec (CER Writer)
Project/Initiative Summary
The CER-OMA team supports clinical-regulatory filings and global medical affairs operations, providing real-time scientific use-case assessments and dissemination.
Team Composition
- 4 Team Members
- Mixed Tenured Scientific Backgrounds
- Strong Medical Writing
- Biostatistics
- Medical Research
- Decades of Industry Experience
Top 5 Responsibilities
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, representing Clinical in cross-functional planning and helping the organization understand the clinical implications of decisions.
Must Have Skills/Attributes
Exceptional medical writing experience (years of experience not specified).
Deep clinical research and clinical evidence development experience (years of experience not specified).
Expert-level ability to write, edit, and finalize documents (years of experience not specified).
Connect scientific evidence to regulatory, commercial, and clinical needs (years of experience not specified).
Exceptional medical writing and scientific communication (years of experience not specified).
Nice to Have Skills/Attributes
Foundational cardiac knowledge and experience with electrophysiology procedures/technology (years of experience not specified).
Interview Process
- 2-3 Rounds
- Video and Phone Interviews as Needed