Sr. Clinical Evaluation Medical Writer

Title: Sr. Clinical Evaluation Medical Writer
Location: Mounds View, MN (Hybrid- 4 Days Onsite)
Duration: 24 Months+ Possible Extension

Top Needs:
1. Clinical Evaluation experience (end to end would be ideal)
2. Experience with cardiac rhythm management devices (ideal)
3. Experience with literature management tools (ReadCube is ideal)

Job Description:

• This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety and performance and identify potential data gaps or risks.
• The position leads and supports clinical evaluations in compliance with applicable global regulatory requirements, working closely with crossfunctional stakeholders to define clinical evaluation strategies and support regulatory interactions.
• The role requires maintaining current knowledge of clinical evaluation best practices and the evolving clinical and regulatory landscape, and producing clear, accurate, and highquality clinical documentation.
• Responsibilities also include supporting risk/benefit and stateoftheart assessments, managing document timelines, addressing regulatory feedback, and providing guidance or mentoring to colleagues as needed.

Education Required:
Years Experience Required:

• Bachelors degree with a minimum of 4 years of experience in clinical research/clinical evaluation/clinical evidence, or advanced degree with a minimum of 2 years of experience in clinical research/clinical evaluation/clinical evidence

Responsibilities may include the following and other duties may be assigned.

• Identify, compile and analyze multiple data types (clinical investigation results, literature and clinical experience, preclinical data, etc.) in order to evaluate product safety and performance and identify potential evidence gaps
• Collaborate, plan and develop clinical evaluations in accordance with relevant guidelines/regulations (i.e. CERs, clinical dossiers) with stakeholders from multiple functions and in compliance with applicable standards and in alignment with business needs
• Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear and concise reports
• Identify potential evidence gaps or risks to existing data and work with stakeholders to assess options, track, and communicate risks as needed
• Develop search strategies to identify and obtain existing, relevant data (internal or external)
• Stay current on clinical evidence landscape and provide guidance to teams on sufficient data
• Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies guidelines on clinical evaluation requirements
• Assess other technical file documents aProductst clinical data, available current literature and industry state of the art (this may include risk management plans, IFU, etc.)
• Collaborate with other functional groups (R&D, clinical, quality, marketing, etc.) to conduct risk/benefit assessments and evaluate State of the Art for the therapy area and product line
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
• Address deficiencies and or answer questions from regulatory agencies as needed
• Work in close collaboration with cross-functional stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial design
• Interface with regulators and may lead discussions and develop strategies with cross functional stakeholders to negotiate and influence regulatory reviewers on the clinical evaluation
• Provide guidance, mentoring and coaching to colleagues
• Create and manage project schedule for each document
• May lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical department