Senior Medical Writer

November 26

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• 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.