Clin Evaluation Med Writer
Job Location: Virtual, MN
Duration: 12 Months
Shift Schedule: 1st Shift
Summary:
The Senior Clinical Evaluation Medical Writer is responsible for authoring, reviewing, and managing clinical evaluation documents and reports in compliance with regulatory requirements and industry standards. This role involves synthesizing clinical data, scientific literature, and regulatory guidelines to create clear, concise, and evidence-based documentation that supports the safety and performance of medical devices. The writer collaborates closely with cross-functional teams to ensure the timely delivery of high-quality clinical evaluation reports (CERs) and related documents. Strong analytical skills, attention to detail, and the ability to communicate complex medical and scientific information effectively are essential for success in this role.
Responsibilities:
- Review and summarize scientific literature.
- Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
- Conduct comprehensive literature searches and perform critical evaluation 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 (ProductF-P), Post-Market Clinical Follow-up Reports (ProductF-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.
Required Skills:
- 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 (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)) and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.