Senior Medical Writer, Clinical Evaluation

RXinsider LTD.; Maple Grove (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is a global healthcare leader seeking a Senior Medical Writer, Clinical Evaluation to author Clinical Evaluation documentation for Neuromodulation, CAHF and Vascular products.

The role requires 3+ years in medical writing, clinical study design/management, and strong communication skills. On-site opportunities exist in Maple Grove MN with collaboration across QA, Regulatory and R&D teams.

Qualifications

• Bachelor’s degree in a Science, Medical Technology or equivalent technical field or equivalent experience.
• Minimum 3 years’ relevant experience in R&D, Technical Product Development, or Quality in healthcare.
• Strong written and verbal communication, interpersonal, presentation, analytical and project management skills.
• Experience writing, editing and managing engineering and technical documentation for new products or improvements.
• Experience developing spreadsheets or databases for metrics and data presentation.
• Experience with validation, risk management or quality systems related to medical technology.

Responsibilities

• Write and contribute to Clinical Evaluation reporting deliverables (CERs, CEPs, PMS/PMCF plans and reports).
• Evaluate clinical evidence from literature, investigations and post-market data.
• Collaborate with cross-functional teams to plan CER projects.
• Support regulatory, quality and engineering deliverables.
• Communicate with Sales, R&D, Regulatory, and other stakeholders to complete CER deliverables.
• Ensure data integrity and compliance with ISO and regulatory guidance.

Skills

Written communication

Interpersonal skills

Presentation skills

Analytical skills

Project management

Editing and documenting

Spreadsheet/database development

Regulatory understanding

Education

Bachelor’s degree in science/medical technology

Advanced degree (preferred)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Abbott is a global healthcare leader seeking a Senior Medical Writer, Clinical Evaluation to author Clinical Evaluation documentation for Neuromodulation, CAHF and Vascular products.

The role requires 3+ years in medical writing, clinical study design/management, and strong communication skills. On-site opportunities exist in Maple Grove MN with collaboration across QA, Regulatory and R&D teams.