Senior Medical Writer – FSP

This is a fully remote position, open to applicants in Poland, +3 more states.

📋 Description

• Create and sustain clinical and regulatory documents such as Clinical Trial Reports, Clinical Trial Protocols, protocol amendments, Investigator's Brochures, biomarker reports, and submission documents.

• Oversee clinical documents within the Electronic Document Management System, including document setup, workflow management, and approvals.

• Define, communicate, and uphold project timelines with trial and project teams.

• Organize, facilitate, and document project, kick-off, Results Alignment, trial team, and submission meetings.

• Compose clinical documents incorporating suitable in-text tables and figures.

• Manage document review cycles, promote consensus on feedback, integrate revisions, and complete review documentation.

• Initiate, conduct, or supervise quality control activities and complete accompanying documentation.

• Finalize and deliver completed documents while supporting publishing and pre-archive activities.

• Execute technical and formatting checks for Investigator's Brochures and related updates.

• Assist with final electronic approval processes, ensuring adherence to procedures, systems, and standard operating procedures.

• Collaborate within integrated cross-functional teams and engage in project governance, feedback, and alignment activities.

⛳️ Requirements

• Bachelor's degree or an equivalent combination of education and relevant experience.

• Familiarity with clinical development documentation processes and regulated work environments.

• Experience with Electronic Document Management Systems and document lifecycle management processes.

• Proficient in medical writing, project coordination, and document management.

• Background in clinical research or another regulated setting is advantageous.

• Ability to collaborate across teams and communicate effectively with diverse stakeholders.

• Quality-driven mindset with a keen attention to detail.

• Comfortable with electronic document management systems, document review processes, and quality control protocols.

• Strong skills in communication, organization, stakeholder management, and problem-solving.

• Advanced educational background in scientific, life sciences, or related fields is preferred.

• Experience in supporting clinical trial documentation and regulatory submissions is preferred.

• Familiarity with clinical document review, quality control, publishing, and approval workflows is preferred.

• Experience collaborating within cross-functional clinical development teams is preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible work hours and remote work options.

• Generous vacation and paid time off policies.