Senior 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 Senior Medical Writer 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 collaboration.
• Manage document review cycles by integrating revisions, driving stakeholder alignment, and overseeing quality control processes.
• Ensure all documentation adheres to established procedures, compliance standards, and project timelines.

Requirements

• Bachelor's degree or an equivalent combination of education and relevant professional experience.
• Proven experience in clinical research or a similarly regulated environment with a focus on documentation.
• Strong proficiency in using Electronic Document Management Systems and managing document lifecycles.
• Excellent communication, organizational, and stakeholder management skills with a high attention to detail.
• Ability to work effectively within integrated, cross-functional teams to meet critical study milestones.

What we offer

• The opportunity to contribute to the delivery of life-changing therapies in a fast-paced, growth-oriented environment.
• Deep involvement in clinical development processes and exposure to global regulatory submission standards.
• A collaborative culture that values bold thinking, empathy, and a shared purpose in advancing clinical research.