Medical Writer II - 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 Medical Writer II to join our team as a dedicated, embedded resource, supporting the development of high-quality clinical and regulatory documentation that advances patient care.

Key responsibilities

• Develop and maintain essential clinical and regulatory documents, including Clinical Trial Reports, protocols, amendments, and Investigator's Brochures.
• Manage document lifecycles within Electronic Document Management Systems, ensuring proper setup, workflow management, and final approvals.
• Coordinate and facilitate project meetings, including kick-off and results alignment sessions, to ensure cross-functional team alignment.
• Manage document review cycles by integrating revisions, driving consensus on comments, and completing necessary review documentation.
• Perform quality control oversight and technical checks to ensure all deliverables meet regulatory standards and internal procedures.

Requirements

• At least 1 year of professional experience as a Medical Writer in a clinical research or regulated environment.
• Bachelor's degree or an equivalent combination of education and relevant industry experience.
• Strong proficiency with Electronic Document Management Systems and document lifecycle management processes.
• Excellent communication, organizational, and stakeholder management skills with a keen attention to detail.
• Ability to work effectively within integrated, cross-functional teams to meet critical study and submission milestones.

What we offer

• Opportunity to contribute directly to the delivery of clinical research programs and the advancement of new therapies.
• A fast-paced, growth-oriented environment that fosters professional development and deepens knowledge of clinical processes.
• Collaborative culture focused on quality, innovation, and making a meaningful difference for patients worldwide.