Sr Clin Eval Med Writer - Exempt

Lancesoft; Coon Rapids (MN); Hybrid; USD 95,000 - 140,000; Full time

Job summary

Lancesoft seeks a Senior Clinical Evaluation Medical Writer to author, review, and manage clinical evaluation documents and CERs, ensuring regulatory compliance and evidence-based narration.

You will synthesize clinical data, literature, and guidelines, collaborating with cross-functional teams to deliver timely, high-quality reports and related regulatory documents.

Qualifications

• Knowledge of regulatory guidelines for clinical evaluation requirements.
• Experience writing clinical evaluation documents for medical devices.
• 4+ years of relevant experience, or 2+ years with an advanced degree.

Responsibilities

• Review and summarize scientific literature.
• Appraise, analyze, summarize, and discuss clinical evidence.
• Conduct comprehensive literature searches and critical evaluations.
• Maintain a database of peer‑reviewed literature.
• Develop state of the art (SOTA) on product family for its intended purpose.
• Create and maintain CEP, CER, PMCF-P, PMCF-R, SSCP, PSUR documents.
• Report adverse events from literature and prepare audit responses.

Skills

Regulatory guidelines

Clinical writing

Medical device experience

Project management

Communication

Stakeholder collaboration

Education

Bachelor's degree in a relevant field

Advanced degree (preferred)

Job description

Join our dynamic team as a Senior Clinical Evaluation Medical Writer, where you will play a crucial role in authoring, reviewing, and managing clinical evaluation documents and reports. This position ensures compliance with regulatory requirements and industry standards, synthesizing clinical data, scientific literature, and regulatory guidelines to create clear, concise, and evidence-based documentation. Collaborate closely with cross‑functional teams to ensure the timely delivery of high-quality clinical evaluation reports (CERs) and related documents.

Remote role offers the flexibility of working from Virtual, MN.

Key Responsibilities

• Review and summarize scientific literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
• Conduct comprehensive literature searches and perform critical evaluations of clinical evidence.
• Maintain a database of peer‑reviewed literature.
• Develop state of the art (SOTA) on product family for its intended purpose.
• Create and maintain plans and reports for regulatory authorities, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up Plans (PMCF-P), Post-Market Clinical Follow-up Reports (PMCF-R), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR).
• Report instances of complaints/adverse events from literature.
• Create responses for audit/submission queries.

Job Requirements

• Knowledge of regulatory agencies’guidelines on clinical evaluation requirements.
• Experience writing clinical evaluation documents.
• Medical Device experience.
• Strong project management skills.
• Strong communication skills.
• Ability to deliver and manage projects assigned and work with other stakeholders to achieve desired results.
• Baccalaureate degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.