Medical Writer Job at Randstad USA in Durham

Job Summary:
We are seeking a Medical Writer with extensive experience writing Clinical Study Reports for In Vitro Diagnostics (IVD). This is a fully remote 40-hour per week, contract opportunity that will last through the end of 2025.

Location: Durham, North Carolina
Job Type: Contract
Salary: $90 - 110 per hour
Work Hours: 9 to 5
Education: Masters

Responsibilities:

• Deliver Clinical Study Reports (CSR) for 2 IVD studies.
• Collaborate with members of cross-functional teams to prepare high-quality regulatory documents and clinical study-related documents.
• Track progress on projects and provide regular updates to project lead and cross-functional teams through written and verbal communication (including team meetings).
• Perform hands-on writing work, ensuring accountability for deliverables, setting up necessary meetings, and owning the review process.

Qualifications:
Required:

• Bachelor's degree or equivalent in a medical-related or life science field.
• At least 3 years of medical writing experience, preferably for in vitro diagnostics (IVD); pharmaceutical, biologics, or medical device experience also acceptable.
• Proficient with Zotero reference management software.

Preferred:

• Advanced Degree.

Skills: CSR, GCP (Good Clinical Practice), CTD Structure, ICH Regulations.

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