Medical Writer, Clinical

Clinical Project Manager (Medical Writer)

8-month contract

Onsite in Lake Forest, IL

Job Summary:

Our medical device client is seeking a Clinical Project Manager to support their IVDR remediation program by ensuring compliance in a timely manner. This role will involve data generation, literature searches, medical writing, and clinical study execution to support both on-market and new products requiring IVDR compliance.

The ideal candidate will have experience in clinical research, medical writing, literature review protocols, and study execution with proficiency in Microsoft Word for document tracking and formatting.

Key Responsibilities:

• Conduct literature searches, data collation, and dissemination to generate clinical performance reports for IVDR remediation.
• Develop literature search protocols and interpret/select relevant scientific literature.
• Write, review, and update clinical performance reports annually.
• Support clinical study start-up and execution for IVDR compliance, including data collection and reporting.
• Assist with IVDR study execution for both on-market and new products.
• Ensure regulatory and compliance documentation aligns with IVDR requirements.
• Format, track, and finalize documents to a signable state using Microsoft Word.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, or a related field.
• 3+ years of experience in clinical research, medical writing, or regulatory affairs in the medical device industry.
• Strong expertise in medical writing and literature review methodologies.
• Proficiency in Microsoft Word (creating, tracking changes, and formatting documents).
• Knowledge of IVDR regulations and clinical performance reporting requirements is a plus.
• Excellent analytical, organizational, and communication skills.