Sr. Clinical Evaluation Medical Writer

Job Description

Job Summary:

• 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 cross‐functional 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 high‐quality clinical documentation.
• Responsibilities also include supporting risk/benefit and state‐of‐the‐art assessments, managing document timelines, addressing regulatory feedback, and providing guidance or mentoring to colleagues as needed.

Duties and Responsibilities:

• 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.

Education & Experience Required:

• Bachelor’s 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.

Top 3 skills:

• Clinical Evaluation experience (end to end would be ideal).
• Experience with cardiac rhythm management devices (ideal).
• Experience with literature management tools (ReadCube is ideal).