Documentation Specialist / Medical Writer - FSP

Parexel is a leading global clinical development partner dedicated to improving world health through innovative clinical and consulting solutions. We are currently seeking a Documentation Specialist / Medical Writer to join our team as a fully remote, embedded resource, contributing to the development of high-quality clinical and regulatory documentation that advances life-saving therapies.

Key responsibilities

• Develop and maintain essential clinical and regulatory documents, including Clinical Trial Reports, protocols, and Investigator's Brochures.
• Manage document lifecycles within the Electronic Document Management System, ensuring proper setup, workflow management, and approvals.
• Coordinate and facilitate document review cycles, driving alignment among cross-functional teams and integrating revisions.
• Conduct quality control activities and ensure all documentation meets rigorous compliance standards and procedural requirements.
• Collaborate with project teams to establish and maintain project timelines, ensuring the timely delivery of submission-ready documents.

Requirements

• Bachelor's degree or an equivalent combination of education and relevant professional experience.
• Proven experience in technical or medical writing within a clinical research or highly regulated environment.
• Strong proficiency in working with Electronic Document Management Systems and document lifecycle processes.
• Excellent communication, organizational, and stakeholder management skills with a keen attention to detail.
• Ability to work effectively within integrated, cross-functional teams to achieve project milestones.

What we offer

• Opportunity to work in a fast-paced, growth-oriented environment focused on clinical research innovation.
• Deepen your expertise in clinical development processes while supporting critical study and submission milestones.
• Collaborative culture that values bold thinking, empathy, and a shared purpose in improving patient outcomes.