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Senior Medical Writer - Structured Content Authoring - FSP

May 15, 2026

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, Structured Content Authoring 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.

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

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

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4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

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This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...