Senior Medical Writer

Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely.

Location: Remote (anywhere in US or Canada)
Employment Type: Full-time

About Parexel

At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world’s most prominent biopharmaceutical companies to bring life‑changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence—where your expertise can make a real impact on global health.

Role Summary

Parexel is seeking an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows.

The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements.

This position also offers the opportunity to provide end‑user support as the user base grows—making it a great learning experience and a chance to deliver impactful solutions.

Key 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.

Required Qualifications

- 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.

Preferred Qualifications

- 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.

Education

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

Why Join Parexel?

- 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.

Ready to Make an Impact?
If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you

Apply today and join Parexel in shaping the future of clinical research.

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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