$147,000 to $196,800 py; not specified; health, de...
Hybrid
Authoring clinical study documentation
Authoring scientific publications
Reviewing clinical evidence
Responsible for authoring clinical and scientific documentation to support product and therapy approval and use worldwide
Job Summary
Responsible for authoring clinical and scientific documentation to support product and therapy approval and use worldwide.
Develop and maintain clinical documentation for cardiac surgery device regulatory submissions, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Plan/Report (PMCFP/R), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs).
The position offers a hybrid work model with 4 days onsite at Mounds View, MN, and includes benefits such as health, dental, and vision insurance, 401(k) plan with employer contribution, and paid time off.
Matching Summary
Responsible for authoring clinical and scientific documentation to support product and therapy approval and use worldwide.
Salary
$147,000 to $196,800 per year; Not specified; Health, Dental and vision insurance, 401(k) plan plus employer contribution and match, Paid time off, Paid holidays
Skills & Requirements
Must-have
Authoring clinical study documentation
Authoring scientific publications
Reviewing clinical evidence
Responding to regulatory queries
EU MDR submissions
Cardiac ablation devices
Nice-to-have
Key Opinion Leader engagement
Global product approval support
Key Requirements
Masters’ Degree in Biomedical Sciences, Medicine, Pharmacology, or related technical disciplines
Five (5) years of experience as a medical writer
One (1) year EU MDR experience
One (1) year CEPs, CERs, PMCFP/R, SSCP, PSURs experience