Clinical Evaluation Medical Writer

Overview

• Contribute to clinical evaluation processes by authoring comprehensive reports and summaries.
• Collaborate with cross-functional teams to manage projects effectively and ensure timely completion.
• Perform critical evaluations of clinical evidence from diverse sources to support regulatory submissions.
• Maintain and update databases of peer-reviewed literature relevant to clinical evaluations.
• Develop and maintain state-of-the-art documentation for product families and intended purposes.
• Ensure compliance with regulatory guidelines on clinical evaluation requirements.
• Provide responses to audit and submission queries with detailed and accurate information.
• Support the development and approval of documentation for device development.

Key Responsibilities & Duties

• Conduct comprehensive literature searches and summarize findings for clinical evaluation reports.
• Appraise and analyze clinical evidence to support regulatory submissions and product development.
• Collaborate with cross-functional teams to manage projects and achieve desired outcomes.
• Develop and maintain clinical evaluation plans and reports for regulatory authorities.
• Review and approve documentation related to clinical evaluations and device development.
• Provide mentorship and guidance to entry-level professionals in the field.
• Communicate effectively with internal stakeholders to share information and support decision-making.
• Identify and recommend enhancements to systems and processes to improve effectiveness.

Job Requirements

• Bachelor of Science (BS) degree with minimum 4 years of experience, or advanced degree with minimum 2 years of experience.
• Proven experience in Clinical Evaluation Report (CER) writing and project management.
• Ability to manage cross-functional teams and collaborate effectively with diverse stakeholders.
• Strong knowledge of regulatory guidelines for clinical evaluation requirements.
• Proficiency in conducting literature searches and critical evaluations of clinical evidence.
• Excellent communication skills for internal and external interactions.
• Experience in developing and maintaining clinical evaluation plans and reports.
• Ability to work independently on moderately complex projects with general supervision.