Medical Writer II – 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 CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission materials.

• Oversee clinical documents within the Electronic Document Management System (EDMS), managing document setup, workflow, and approvals.

• Set, communicate, and uphold agreed project timelines in partnership with trial and project teams.

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

• Compose clinical documents, incorporating in-text tables and figures, following agreed timelines and relevant procedures.

• Coordinate and manage document review processes, foster alignment on feedback, integrate changes, and complete necessary review documentation.

• Initiate, execute, or supervise quality control activities and finalize supporting quality control documentation.

• Complete and deliver finalized documents to project teams and assist with document publishing and pre-archiving tasks.

• Conduct technical and formatting checks for Investigator's Brochures and associated updates.

• Assist in final electronic approval processes and ensure adherence to established procedures, systems, and standard operating protocols.

• Collaborate in a cohesive team environment and engage in project governance, feedback, and alignment initiatives.

⛳️ Requirements

• Minimum of 1 year of experience as a Medical Writer.

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

• Understanding of clinical development documentation processes and regulated working settings.

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

• Excellent communication, organizational, stakeholder management, and problem-solving abilities.

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

• Prior experience supporting clinical trial documentation and regulatory submissions is preferred.

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

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

🏝️ Benefits

• Chance to enhance understanding of clinical development processes.

• Collaborative team environment.

• Continuous project governance, feedback, and alignment activities.