Senior Medical Writer, Redaction – Clinical Trial Transparency

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Responsible for the authorship and quality assurance of project activities.

• Carries out project-specific tasks with exceptional quality and adherence to established timelines, following standard procedures and operating protocols.

• Conducts marking, quality control, review, and/or editing of relevant documents, including clinical study documents and other regulatory submission materials such as clinical study reports, patient narratives, and clinical summaries, in accordance with various regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH).

• Prepares protocol and results summaries to fulfill clinical trial disclosure obligations.

• Methodically performs quality control evaluations of documents created by colleagues based on a predetermined checklist established within the project or standard operating procedures.

• Carries out in-depth analyses on both a planned and ad hoc basis, focusing on processes and their outcomes.

• Ensures compliance with client processes.

⛳️ Requirements

• Experience in authoring and quality assurance of project activities.

• Ability to execute project-specific tasks with high quality and within defined timelines, in line with standard processes and operating procedures.

• Proficient in marking, quality control, reviewing, and/or editing relevant documents, including clinical study documents and regulatory submission materials such as clinical study reports, patient narratives, and clinical summaries, compliant with various regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH).

• Capable of preparing protocol and results summaries to support clinical trial disclosure commitments.

• Skilled in systematically performing quality control checks on documents prepared by colleagues using a pre-specified checklist created for the project or SOP.

• Experienced in performing detailed analyses on a planned and ad hoc basis regarding processes and their outputs.

• Committed to adhering to client processes.

• Completion of both internal and client-specific training is required.

• Ability to assist in mentoring and training team members as per project requirements.

🏝️ Benefits

• Comprehensive health benefits that include medical, dental, and vision coverage.

• Company-matched 401k plan.

• Opportunity to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.