Parexel

Senior Medical Writer – Structured Content Authoring

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Configure and maintain SCA platform settings to support medical writing and regulatory workflows.
  • Customize templates, metadata fields, and document structures for compliance and efficiency.
  • Implement and validate workflow configurations for review, approval, and version control.
  • Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM).
  • Conduct functional testing and troubleshoot configuration issues.
  • Maintain detailed documentation of configuration changes for audit readiness.
  • Collaborate with internal teams to gather requirements and translate them into technical solutions.
  • Provide user training and support on SCA features and best practices.
  • Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform.
  • Ensure all configurations comply with regulatory standards and company SOPs.

Requirements

  • Proven experience with SCA platforms.
  • Background in medical writing or strong familiarity with regulatory documentation processes.
  • Hands-on experience in content creation, review, standardization, and management within a structured content platform.
  • Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents.
  • Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform.
  • Strong problem-solving skills and attention to detail.
  • Familiarity with compliance and audit requirements in a GxP environment.
  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
Benefits
  • Impactful Work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide.
  • Global Collaboration: Work with diverse teams across the globe in a dynamic, innovative environment.
  • Career Growth: Access to professional development programs, mentorship, and opportunities for advancement.
  • Flexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance.
  • Inclusive Culture: Be part of a company that values diversity, integrity, and collaboration.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
SCA platformscontent creationmetadata managementworkflow configurationfunctional testingtroubleshootingdocument structuresregulatory complianceaudit readinessversion control
Soft skills
problem-solvingattention to detailcollaborationuser trainingsupportcommunication