Clin Eval Med Writer - Exempt

We are seeking a highly skilled professional to join our team as a Clinical Evaluation Medical Writer. This role offers an exciting opportunity to work in a dynamic environment where you will contribute to the development and implementation of clinical evaluation documents in compliance with the European Union Medical Device Regulation (EU MDR). Join us in Lafayette, CO, a vibrant location that offers a great quality of life with its beautiful landscapes and community-focused atmosphere.

Must Have:

• Advanced proficiency in Microsoft Word, including structured formatting, templates, track changes, and document control.
• In-depth understanding of EU MDR safety and performance requirements.
• Expertise in literature analysis for PSUR and client documents.
• Experience as a PSUR Medical Writer.
• Knowledge of Post Market Clinical Follow Up (PMCF) and Periodic Safety Update Report (PSUR) writing in compliance with EU MDR.

Nice to Have:

• 10 years of project management experience and 5 years of program management experience.

Responsibilities:

• Author and maintain Periodic Safety Update Reports and Post Market Clinical Follow Up Plans/Reports.
• Conduct comprehensive literature searches and perform critical evaluations of clinical evidence.
• Develop state-of-the-art documentation for product families and ensure compliance with regulatory authorities.
• Review and summarize scientific literature, and report complaints/adverse events to GCH.
• Create responses for audit/submission queries and maintain a database of peer-reviewed literature.
• Collaborate with stakeholders to achieve project milestones and deliverables.

Education and Experience Required:

• Baccalaureate degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or Public Health, ideally with training in Clinical Research or Regulatory Affairs.
• Minimum 3 years, maximum 10 years of relevant experience in PSUR and PMCF writing, clinical evaluation, or post-market surveillance.

Work Location:

On-site work is preferred in Lafayette, CO; however, remote work is acceptable depending on the candidate's profile and experience. Being local to Lafayette, Colorado, or the MN campus is advantageous but not required.