Clinical Medical Writer — Protocols, CSRs & Regulatory Docs

Systimmune; Princeton (NJ); On-site; USD 80,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Systimmune, located in Princeton, NJ, is seeking a Medical Writer to manage clinical documentation including study protocols and reports. This role requires a Master's degree in life sciences and 3-4 years of experience in pharma.

The successful candidate will ensure documents meet regulatory standards and maintain high quality. The hiring pay range is $80,000 – $130,000 annually, and Systimmune offers a comprehensive benefits package.

Qualifications

• 3-4 years of experience as a medical writer in the pharmaceutical industry.
• Proven experience writing protocols, CSRs, ISE, ISS, and Clinical Overview.
• Knowledge of drug development and regulatory requirements.

Responsibilities

• Manage and oversee medical writing projects including clinical study protocols.
• Write and edit high-quality clinical documentation for regulatory submission.
• Track clinical documentation milestones and ensure quality standards.

Skills

Excellent writing skills

Effective communication skills

Organizational skills

Knowledge of FDA and ICH guidelines

Skilled in clinical data interpretation

Interpersonal skills

Education

Master's degree in life sciences or PhD with 1 year experience

Job description

Systimmune, located in Princeton, NJ, is seeking a Medical Writer to manage clinical documentation including study protocols and reports. This role requires a Master's degree in life sciences and 3-4 years of experience in pharma.

The successful candidate will ensure documents meet regulatory standards and maintain high quality. The hiring pay range is $80,000 – $130,000 annually, and Systimmune offers a comprehensive benefits package.