Sr. Clinical Evaluation Medical Writer

Job Description: Sr. Clinical Evaluation Medical Writer

Location: Mounds View, MN (Onsite – minimum 4 days/week)

Duration: 2 years

Hours: 40 hours/week

Pay Rate: $50.40–$57.40/hr.

Top Needs from Hiring Manager

1. Clinical evaluation experience (end-to-end preferred)
2. Experience with cardiac rhythm management devices (preferred)
3. Experience with literature management tools (ReadCube preferred)

Education & Experience Requirements

• Bachelor’s degree with minimum 4 years of experience in clinical research, clinical evaluation, or clinical evidence

OR

• Advanced degree with minimum 2 years of experience in clinical research, clinical evaluation, or clinical evidence

Role Overview

This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety and performance, and to identify potential data gaps or risks. The position leads and supports clinical evaluations in compliance with global regulatory requirements and collaborates cross-functionally to define clinical evaluation strategies and support regulatory interactions.

The role requires maintaining current knowledge of clinical evaluation best practices and evolving regulatory expectations, while producing high-quality clinical documentation. Responsibilities include supporting risk/benefit and state-of-the-art assessments, managing document timelines, addressing regulatory feedback, and providing mentorship to colleagues as needed.

Key Responsibilities

• Identify, compile, and analyze multiple data types (clinical investigations, literature, clinical experience, preclinical data) to evaluate product safety, performance, and evidence gaps
• Collaborate with cross-functional stakeholders to plan and develop clinical evaluations (e.g., CERs, clinical dossiers) in compliance with regulations and business needs
• Develop and maintain therapeutic and device knowledge to produce clear, concise clinical reports
• Identify evidence gaps/risks and coordinate with stakeholders to assess and communicate mitigation strategies
• Develop literature search strategies to obtain relevant internal and external data
• Stay current on clinical evidence landscape and provide guidance on data sufficiency
• Maintain knowledge of clinical evaluation best practices and global regulatory requirements
• Assess technical documentation (risk management files, IFUs, etc.) against clinical data and state-of-the-art literature
• Collaborate with R&D, clinical, quality, and marketing teams on risk/benefit assessments and state-of-the-art evaluations
• Conduct proofreading, editing, formatting, review integration, and document finalization activities
• Address regulatory deficiencies and respond to agency questions as needed
• Support regulatory discussions and may help negotiate clinical evaluation strategies
• Provide mentoring, coaching, and guidance to team members
• Create and manage project schedules for clinical evaluation deliverables
• Contribute to development of policies, procedures, and process improvements within the clinical function