Sr Clin Eval Med Writer Exempt

Job Title Senior Clinical Evaluation Medical Writer
Job Location Type Remote
Job Type 24-Month Contract (Potential Temp-to-Hire)
Shift Schedule 1st Shift Standard Business Hours

We are seeking an experienced Senior Clinical Evaluation Medical Writer to support clinical evaluation activities for innovative medical device technologies within a highly regulated environment.

This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety performance and potential evidence gaps while ensuring compliance with global regulatory requirements. The ideal candidate brings strong end-to-end clinical evaluation experience excellent scientific writing capabilities and the ability to collaborate effectively with cross-functional stakeholders.

Experience with cardiac rhythm management devices and literature management platforms such as ReadCube is highly preferred.

• Identify compile and analyze multiple sources of clinical evidence including:

  • Clinical investigation data

  • Scientific literature

  • Preclinical data

  • Post-market clinical experience

• Lead and support development of:

  • Clinical Evaluation Reports (CERs)

  • Clinical dossiers

  • Risk/benefit assessments

  • State-of-the-art evaluations

• Develop and execute clinical evaluation strategies aligned with:

  • Global regulations

  • Business objectives

  • Regulatory submission requirements

• Develop literature search strategies and evaluate relevant internal and external clinical evidence

• Assess technical documentation against current literature clinical evidence and industry standards including:

  • Risk management documentation

  • IFUs

  • Technical files

• Collaborate cross-functionally with:

  • R&D

  • Clinical Affairs

  • Quality

  • Regulatory Affairs

  • Marketing

• Identify evidence gaps and communicate risks mitigation plans and recommendations to stakeholders

• Address regulatory authority questions deficiencies and feedback related to clinical evaluation documentation

• Manage document timelines schedules review cycles formatting proofreading and approval processes

• Maintain expertise in evolving clinical evaluation regulations standards and best practices

• Support or influence clinical trial design discussions where appropriate

• Interface with regulatory reviewers and support regulatory strategy discussions

• Provide mentoring guidance and coaching to junior team members

• Support process improvement initiatives policies and departmental procedures

• Bachelors degree required

• Minimum:

  • 4 years of experience in clinical research clinical evaluation or clinical evidence activities
    OR

  • Advanced degree with 2 years of relevant experience

• Strong experience with end-to-end Clinical Evaluation processes

• Excellent scientific and technical writing skills

• Strong understanding of:

  • Clinical evidence generation

  • Global clinical evaluation regulations and guidelines

  • Medical device regulatory environments

• Experience managing multiple projects and document timelines simultaneously

• Strong analytical organizational and communication skills

• Experience with cardiac rhythm management devices

• Familiarity with literature management tools such as ReadCube

• Medical device industry experience within FDA and/or EU MDR regulated environments

• Experience supporting regulatory submissions and responses to health authorities

• Experience mentoring or leading junior colleagues

• Strong clinical evaluation strategist with excellent scientific writing expertise

• Comfortable working in highly collaborative cross-functional environments

• Detail-oriented with strong document management and regulatory compliance discipline

• Able to synthesize complex clinical data into clear concise high-quality documentation