Senior Clinical Evaluation Medical Writer

Overview

• Contribute to clinical evaluation projects as a Senior Medical Writer in a remote, contract-based role.
• Utilize advanced knowledge and experience to deliver high-quality clinical documentation and regulatory submissions.
• Engage in critical evaluation and summarization of scientific literature to support clinical evidence.
• Collaborate with stakeholders to achieve project goals and improve processes.
• Maintain comprehensive databases and reports for regulatory compliance and audits.
• Provide mentorship and guidance to junior professionals within the team.
• Work independently under limited supervision, contributing to organizational objectives.
• Ensure adherence to guidelines and standards set by regulatory agencies.

Key Responsibilities & Duties

• Conduct comprehensive literature searches and critically evaluate clinical evidence.
• Develop and maintain state-of-the-art documentation for product families.
• Create and manage plans and reports for regulatory authorities.
• Review and approve documentation related to device development.
• Summarize scientific literature and report adverse events to relevant stakeholders.
• Collaborate with internal and external customers to exchange information and influence decisions.
• Implement process improvements to enhance job area performance.
• Manage projects, delegate tasks, and review work products for quality assurance.

Job Requirements

• Bachelor of Science degree required; advanced degree preferred.
• Minimum of 4 years of relevant experience in clinical evaluation or medical writing.
• Advanced knowledge of clinical evaluation requirements and regulatory guidelines.
• Proficiency in conducting literature searches and analyzing clinical evidence.
• Strong project management skills with the ability to manage complex processes.
• Excellent communication skills to interact with senior stakeholders and vendors.
• Ability to work independently and mentor junior team members.
• Experience in creating regulatory submissions and audit responses.