Medical Writer - Sponsor Dedicated - Remote
Pubblicato il 02-08-2026 - Parexel in Italia
We are seeking a Medical Writer to join a key Functional Service Provider program supporting one of our key sponsors. As a Medical Writer, you will work as an integrated member of the sponsor team, supporting the preparation and coordination of clinical development documents including Clinical Trial Reports (CTRs), Clinical Trial Protocols (CTPs) and amendments, Investigator Brochures (IBs) and updates, biomarker reports, and submission documents. This role is ideal for a scientifically minded professional who enjoys working in a collaborative environment where accuracy, organization, and attention to detail are essential. You will support document development activities, coordinate administrative processes, and contribute to the delivery of high-quality clinical documentation that supports the advancement of innovative therapies. **Key Responsibilities** + Support the set-up and maintenance of clinical documents within the Electronic Document Management System (EDMS). + Review document status and assist with document workflow activities within sponsor systems. + Coordinate document timelines and support project teams by tracking key deliverables. + Prepare meeting materials and attend trial team and submission meetings, documenting actions and outcomes as required. + Support the organization and documentation of kick-off meetings and Results Alignment Meetings. + Draft sections of clinical documents and contribute to the preparation of tables, figures, and supporting content. + Coordinate document review activities and support the collection and incorporation of stakeholder feedback.
+ Assist with Quality Control activities and completion of required documentation. + Support preparation of final document packages for review, publishing, and archiving activities. + Complete technical and formatting checks for Investigator Brochures and related clinical documents. + Maintain accurate records and documentation in accordance with sponsor procedures and SOPs. **Candidate Profile** You'll thrive in this role if you bring: + Experience supporting medical writing, clinical documentation, or related clinical research activities. + Strong organizational skills and the ability to manage multiple document-related activities simultaneously. + Excellent written communication and attention to detail. + A collaborative approach and willingness to work closely with cross-functional teams. + A patient-focused mindset and commitment to quality. **Required Qualifications** + Scientific degree and/or advanced scientific degree. + 1-3 years of experience within medical writing. + Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes. + Experience working with document management systems and clinical development documentation. + Strong communication, organizational, and problem-solving skills. #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.