Remote Medical Writer – Drug Safety & Pharmacovigilance

Sitero LLC; Raleigh (NC); Remote; USD 55,000 - 83,000; Full time

Job summary

Sitero LLC is seeking a Medical Writer for the Drug Safety team to create and review safety documents across pre- and post-marketing activities. The role emphasizes collaboration with CROs and project teams to ensure compliant reporting and high-quality deliverables.

The ideal candidate has at least 2 years in medical writing, a life sciences degree, and strong communication skills. This is a remote US contract position with competitive hourly compensation.

Qualifications

• Minimum 2 years of Medical Writing experience.
• Degree in Life Science/Pharma or Equivalent.
• Strong communication and organizational skills.

Responsibilities

• Analyze safety data from clinical and non-clinical sources.
• Author and review PSURs, PBRERs, and DSURs for regulatory submissions.
• Prepare Risk Management Plans and Clinical Study Reports.
• Mentor Pharmacovigilance staff and maintain trackers.
• Ensure deliverables meet regulatory requirements and deadlines.

Skills

Medical Writing

Regulatory awareness

Communication skills

Pharmacovigilance knowledge

Education

Bachelor's degree in Life Science/Pharma

Tools

Microsoft Office

Job description

Sitero LLC is seeking a Medical Writer for the Drug Safety team to create and review safety documents across pre- and post-marketing activities. The role emphasizes collaboration with CROs and project teams to ensure compliant reporting and high-quality deliverables.

The ideal candidate has at least 2 years in medical writing, a life sciences degree, and strong communication skills. This is a remote US contract position with competitive hourly compensation.