Senior Medical Writer, Sponsor Dedicated

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

📋 Description

• Providing Medical Writing Services for the development of clinical documents such as CTRs, CTPs and amendments, IBs and updates, biomarker reports, and submission materials.

• Managing documents within the EDMS.

• Reviewing and approving Statistical Analysis Plans in the EDMS.

• Overseeing timelines and continuously updating schedules.

• Preparing for and participating in trial team and submission meetings.

• Organizing, conducting, and documenting kick-off meetings.

• Organizing, conducting, and documenting Results Alignment Meetings when applicable.

• Drafting documents including tables and figures in accordance with established timelines.

• Managing review cycles, reconciling comments, and documenting reviews.

• Initiating, monitoring, or conducting Quality Control reviews and related documentation.

• Creating and delivering final document versions to project teams.

• Providing publishing support, performing pre-archive checks, and addressing findings.

• Electronically approving final clinical documents in the EDMS.

• Conducting technical and formatting checks for IBs and updates.

• Ensuring compliance with sponsor processes and SOPs.

• Participating in governance, feedback, and alignment meetings.

⛳️ Requirements

• Prior experience as a Medical Writer or Senior Medical Writer.

• Strong collaboration and communication abilities.

• Exceptional attention to detail and a focus on document quality.

• A patient-centered approach and dedication to advancing clinical research.

• A scientific degree and/or an advanced scientific qualification.

• A minimum of 5 years of experience in medical writing.

• Familiarity with ICH GCP, regulatory requirements, and clinical trial processes.

• Experience with clinical document management systems and associated tools.

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

🏝️ Benefits

• Flexibility, opportunities for growth, and fostering an environment for individuals to perform at their best.

• Professional development.