Consultant I, Medical Writing

🕒 June 22

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials. • Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications). • Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines. • Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands. • Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines. • Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust. • Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards. • Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents. • Contribute to the development of regulatory strategies for early-stage and smaller clients. • Provide guidance on tools, document management systems, and client SOPs. • Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship.

🎯 Requirements

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred. • RAC certification is beneficial. • 3+ years industry experience • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project. • Familiarity with regulatory document management systems, such as Veeva Vault. • Experience with regulatory submissions and understanding of global regulatory standards.

🏖️ Benefits

• market competitive base salary and annual incentive plan • robust benefit offerings • ongoing recognition and career development opportunities • generous flexible paid time off program • company paid holidays • flexible working hours • fully remote or hybrid work options for some roles