Parexel · 8 hours ago
Project Manager, Structured Content Authoring - FSP
United States
Full-time
Remote
Mid LevelParexel is a leading global clinical research organization dedicated to improving patient lives through innovative clinical research and regulatory solutions. They are seeking an experienced Project Manager, Structured Content Authoring to support the Structured Content Authoring initiative, focusing on configuring the platform for medical writing and regulatory documentation workflows.
Pharmaceuticals
Responsibilities
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
Qualification
Required
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
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Preferred
Experience training users or driving adoption of structured content methods
Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms
Experience working in a CRO or pharmaceutical environment
Knowledge of electronic submission standards (e.g., eCTD)
Strong communication skills for cross-functional collaboration
Ability to work independently and manage multiple priorities
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.
Company
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
Founded in 1983
10001+ employees
H1B Sponsorship
Parexel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (46)
2023 (41)
2022 (51)
2021 (54)
2020 (33)
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
Company data provided by crunchbase