Safety Writer – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Create detailed safety assessment reports, which encompass signal evaluations.

• Draft and prepare responses to Information Requests from the FDA.

• Develop and compose core safety reference information or justifications for safety components of labels.

• Design and prepare slides for safety-focused presentations for both internal and external meetings, including those for FDA advisory committees.

• Work collaboratively with cross-functional teams to guarantee the consistency and thoroughness of safety narratives and analyses.

• Participate in risk-benefit analyses, writing Risk Management Plans (RMPs), and contributing to safety sections for clinical and safety documentation, such as Investigator Brochures (IBs) and Clinical Study Reports (CSRs).

• Aid in the drafting, editing, formatting, and upkeep of safety-related Standard Operating Procedures (SOPs) and work instructions.

• Ensure that SOPs conform to current regulatory standards and internal quality benchmarks.

• Assist in activities related to inspection readiness.

⛳️ Requirements

• An advanced degree in life sciences, pharmacy, nursing, public health, or a related scientific discipline (a doctorate is preferred).

• Over 8 years of experience in medical writing or as a safety scientist, with a strong emphasis on safety, clinical, or regulatory documentation.

• Experience in writing safety signal assessment documents.

• Previous involvement in the preparation and writing for FDA advisory committee meetings is highly regarded.

• Proven experience in drafting responses to FDA Information Requests related to safety issues.

• A solid understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management.

• Demonstrated capability to review and analyze adverse event data.

• Knowledge of global regulatory requirements (such as EMA, PMDA, etc.).

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Generous paid time off and holiday policies.

• Opportunities for professional development and continuing education.

• Flexible work arrangements.