Documentation Specialist – Medical Writer

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

📋 Description

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

• Oversee clinical documents in the Electronic Document Management System, including setting up documents, managing workflows, and securing approvals.

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

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

• Compose clinical documents with relevant in-text tables and figures, adhering to timelines and established procedures.

• Manage document review cycles, promote alignment of comments, incorporate revisions, and finalize review documentation.

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

• Finalize and distribute documents to project teams, and assist with publishing and pre-archival tasks.

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

• Assist with final electronic approval processes and ensure compliance with procedures, systems, and standard operating procedures.

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

⛳️ Requirements

• Proven experience in technical writing or medical writing.

• Background in clinical research or within another regulated environment.

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

• Detail-oriented with a strong focus on quality.

• Proficiency in working with electronic document management systems, document review procedures, and quality control processes.

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

• Understanding of clinical development documentation processes and regulated work environments.

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

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

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

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

• Knowledge of clinical document review, quality control, publishing, and approval workflows is preferred.

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

🏝️ Benefits

• N/A