Company: Parexel is on the lookout for a talented Senior Medical Writer with expertise in Structured Content Authoring to join our dynamic team.
Location: Remote (available anywhere in the US or Canada)
Employment Type: Full-time
About Parexel
At Parexel, we strive to enhance patient lives through groundbreaking clinical research and regulatory solutions. As a premier global clinical research organization (CRO), we collaborate with leading biopharmaceutical companies to introduce transformative therapies to the market. Our culture emphasizes teamwork, integrity, and a solid commitment to excellence—where your knowledge can significantly influence global health.
Role Summary
We are searching for an experienced Senior Medical Writer who will focus on supporting our Structured Content Authoring (SCA) initiative. This critical role specializes in configuring our platform to streamline medical writing and regulatory documentation processes.
In this position, you will merge technical expertise with a deep understanding of structured content and regulatory standards. Your role will be pivotal in ensuring optimal configuration, integration, and enhancement of SCA to meet our varied project and compliance needs.
This position also provides the unique chance to support end-users as our community grows, offering an enriching learning opportunity and the chance to implement impactful solutions.
Key Responsibilities
Configure and maintain SCA platform settings to optimize medical writing and regulatory workflows.
Customize templates, metadata fields, and document structures to ensure compliance and efficiency.
Implement and validate configurations for review, approval, and version control workflows.
Facilitate SCA integration with other enterprise systems, such as PleaseReview and Veeva RIM.
Conduct functional testing and resolve configuration issues promptly.
Document all configuration changes meticulously for audit readiness.
Collate internal team requirements and convert them into effective technical solutions.
Train users and provide support on SCA features and best practices.
Assist with onboarding and troubleshooting for new users, enhancing their experience on the platform.
Ensure all platform configurations adhere to regulatory standards and company SOPs.
Required Qualifications
Proven experience with SCA platforms.
Background in medical writing or a strong grasp of the regulatory documentation process.
Hands-on experience in content creation, standardization, and management within a structured content platform.
Capability to collaborate across functions to ensure regulatory consistency and content harmonization.
Familiarity with core content reuse strategies and metadata management within the platform.
Strong problem-solving skills complemented by attention to detail.
Awareness of compliance and audit requirements in a Good Practice (GxP) environment.
Solid understanding of clinical research, the drug development process, and relevant industry regulations such as ICH-GCP.
A scientific background with writing experience covering various clinical documents including study reports, protocols, or comparable CTD documents.
Fluent in written and spoken English, demonstrating excellent command over grammar and punctuation.
Preferred Qualifications
Experience in training users or promoting the adoption of structured content methods.
Hands-on experience with the automation of regulatory medical writing documents and SCA platforms.
Experience in a CRO or pharmaceutical setting.
Knowledge of electronic submission standards (e.g., eCTD).
Exceptional communication skills for effective cross-functional collaboration.
Ability to independently manage multiple priorities.
Education
Bachelor's degree in Life Sciences or related fields.
Why Join Parexel?
Impactful Work: Contribute towards accelerating the delivery of life-saving therapies to patients globally.
Global Collaboration: Engage with diverse teams around the globe in an innovative environment.
Career Growth: Access opportunities for professional development, mentorship, and career advancement.
Flexibility: Enjoy the advantages of a fully remote role while maintaining a healthy work-life balance.
Inclusive Culture: Join a company that values diversity, integrity, and teamwork.
Apply today and become a part of Parexel's mission to shape the future of clinical research!
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will be considered 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.