Sr Clin Eval Med Writer - Exempt

Join our dynamic team as a Senior Clinical Evaluation Medical Writer where you will play a crucial role in the development and management of clinical evaluation documents to support regulatory submissions. This remote position offers the flexibility to work from anywhere, with a virtual office based in Virtual, MN.

Top Needs

• Strong Clinical Evaluation experience, including writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Follow Up Plan (PMCF P), Post Market Follow up Report (PMCF R), Summary of Safety Clinical Performance (SSCP), and Periodic Safety Update Report (PSUR).
• Strong project management skills.
• Strong proactive communication skills.

Education and Experience Required

• Baccalaureate degree with a minimum of 4 years relevant experience OR advanced degree with a minimum of 2 years relevant experience.

Work Schedule and Location

• Full-time, 40 hours per week.
• Remote position, no need to be local to any MDT office.
• No on-site presence required.

Responsibilities

• Review and summarize scientific literature.
• Report instances of complaints/adverse events from literature to GCH.
• Create responses for audit/submission queries.
• Maintain a database of peer-reviewed literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
• Conduct comprehensive literature searches and perform a critical evaluation of clinical evidence.
• Develop state of the art on product family for its intended purpose.
• Create & maintain plans and reports for regulatory authorities.
• Review/approve other documentation for device development.
• Demonstrate knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

Role and Impact

This position is a specialist career stream, typically an individual contributor role with responsibility in a professional discipline or specialty. The role involves delivering and managing projects, building relationships, and achieving desired results while adhering to policies. It requires advanced knowledge of the job area, typically obtained through advanced education combined with experience.

Skills and Competencies

• Autonomy: Works independently under limited supervision, coaches and reviews the work of lower-level specialists, and may manage projects/processes.
• Organizational Impact: Responsible for entire projects or processes within the job area, contributing to work group objectives.
• Innovation and Complexity: Addresses complex problems and issues, making improvements to enhance performance.
• Communication and Influence: Communicates with senior internal and external customers, exchanges information to achieve objectives, and influences decision-making.
• Leadership and Talent Management: Provides guidance, coaching, and training to other employees, and may manage projects requiring delegation and review of others' work.