Protocol Writer I

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

📋 Description

• Collaborate with clinical investigators to draft, revise, and finalize clinical trial protocols and associated documentation.

• Write, edit, and compile technical and scientific materials under the guidance of the Principal Investigator.

• Develop, prepare, and present comprehensive clinical protocol proposals to the Scientific Review Committee.

• Partner with the Clinical Trials Office to ensure compliance with Moffitt's standards and regulatory guidelines.

• Collaborate with the Principal Investigator and external sponsors on study design.

• Assist in clinical science editing tasks.

• Work alongside Grant Administrators on the clinical research components of selected grant submissions.

• Create protocols and related documents for NIH-defined clinical trials.

• Oversee multiple concurrent projects with varying deadlines.

⛳️ Requirements

• Bachelor's Degree.

• Strong background in scientific, medical, or health-related fields.

• Minimum of 2 years of relevant experience in the medical writing industry.

• Established record of producing high-quality regulatory documents.

• Preferred experience in clinical research.

• MA, MS, MD, PharmD, or PhD with at least 1 year of scientific and/or clinical research experience is preferred.

🏝️ Benefits

• Equal Employment Opportunity/Affirmative Action Employer.

• Reasonable accommodations available for qualified individuals with disabilities.

• Accessible application process and alternate-format documents provided when necessary.