Sr Clin Eval Med Writer - Exempt
Job Description
Join our team as a Clinical Evaluation Medical Writer and contribute to meaningful projects in a fully remote role based out of Virtual, MN. Leverage your expertise to make a significant impact in the medical writing field while enjoying the flexibility of working from anywhere.
Key Responsibilities
ā¢ Review and summarize scientific literature, and report instances of complaints/adverse events to GCH.
ā¢ Create responses for audit/submission queries and maintain a database of peer-reviewed literature.
ā¢ Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
ā¢ Conduct comprehensive literature searches and perform critical evaluations of clinical evidence.
ā¢ Develop state-of-the-art documentation on product families for their intended purpose.
ā¢ Create and maintain plans and reports for regulatory authorities.
ā¢ Review and approve other documentation for device development.
ā¢ Apply knowledge of regulatory agencies'guidelines on clinical evaluation requirements.
Qualifications
ā¢ Bachelor's degree with a minimum of 4 years of experience, or an advanced degree with a minimum of 2 years of experience.
ā¢ Proven experience in Clinical Evaluation Report (CER) writing.
ā¢ Strong project management skills and the ability to manage cross-functional teams.
ā¢ Advanced knowledge of the job area, combining breadth and depth, typically obtained through advanced education and experience.
Additional Information
ā¢ Work Schedule: 40 hours/week
ā¢ Work Location: Remote (Virtual, MN)
ā¢ No requirement to be local to any MDT office or to be on-site.
Why Join Us?
This role offers the opportunity to work independently under limited supervision, allowing you to determine and develop solutions while coaching and reviewing the work of lower-level specialists. You will contribute to the completion of work group objectives by building relationships and consensus, and your analysis will often provide recommendations for process improvements. Communicate with senior internal and external customers and vendors to exchange information and influence decision-making.
Meet Your Recruiter
Natarajan S
Apply Now
Apply Now
Join our team as a Clinical Evaluation Medical Writer and contribute to meaningful projects in a fully remote role based out of Virtual, MN. Leverage your expertise to make a significant impact in the medical writing field while enjoying the flexibility of working from anywhere.
Key Responsibilities
ā¢ Review and summarize scientific literature, and report instances of complaints/adverse events to GCH.
ā¢ Create responses for audit/submission queries and maintain a database of peer-reviewed literature.
ā¢ Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
ā¢ Conduct comprehensive literature searches and perform critical evaluations of clinical evidence.
ā¢ Develop state-of-the-art documentation on product families for their intended purpose.
ā¢ Create and maintain plans and reports for regulatory authorities.
ā¢ Review and approve other documentation for device development.
ā¢ Apply knowledge of regulatory agencies'guidelines on clinical evaluation requirements.
Qualifications
ā¢ Bachelor's degree with a minimum of 4 years of experience, or an advanced degree with a minimum of 2 years of experience.
ā¢ Proven experience in Clinical Evaluation Report (CER) writing.
ā¢ Strong project management skills and the ability to manage cross-functional teams.
ā¢ Advanced knowledge of the job area, combining breadth and depth, typically obtained through advanced education and experience.
Additional Information
ā¢ Work Schedule: 40 hours/week
ā¢ Work Location: Remote (Virtual, MN)
ā¢ No requirement to be local to any MDT office or to be on-site.
Why Join Us?
This role offers the opportunity to work independently under limited supervision, allowing you to determine and develop solutions while coaching and reviewing the work of lower-level specialists. You will contribute to the completion of work group objectives by building relationships and consensus, and your analysis will often provide recommendations for process improvements. Communicate with senior internal and external customers and vendors to exchange information and influence decision-making.
Meet Your Recruiter
Natarajan S
Apply Now
Apply Now