Senior Clinical Evaluation Writer (Remote)

Planet Pharma; Minnesota; Hybrid; USD 73,000 - 80,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Evaluation Medical Writer for remote work to author, review, and manage clinical evaluation documents and reports. You will synthesize clinical data, literature, and regulatory guidance to support the safety and performance of medical devices, collaborating with cross‑functional teams to ensure timely delivery of CERs and related reports.

The role requires strong analytical skills, attention to detail, and clear communication of complex medical

Qualifications

• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
• Experience writing clinical evaluation documents.
• Medical device industry experience.

Responsibilities

• Review and summarize scientific literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
• Conduct literature searches and critically evaluate clinical evidence.
• Maintain database of peer‑reviewed literature.
• Develop state of the art on product family for its intended purpose.
• Create and maintain CEPs, CERs, PMCF-Ps, PMCF-Rs, SSCP, PSURs for regulatory authorities.
• Report adverse events from literature and respond to audit/submission queries.

Skills

Strong project management

Strong communication

Stakeholder collaboration

Clinical evaluation knowledge

Education

Baccalaureate degree

Advanced degree with 2+ years relevant experience

Job description

Planet Pharma is seeking a Senior Clinical Evaluation Medical Writer for remote work to author, review, and manage clinical evaluation documents and reports. You will synthesize clinical data, literature, and regulatory guidance to support the safety and performance of medical devices, collaborating with cross‑functional teams to ensure timely delivery of CERs and related reports.

The role requires strong analytical skills, attention to detail, and clear communication of complex medical