[Hiring] Consultant I, Medical Writing @Syner-G

Role Description

The MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards. This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross-functional teams to meet diverse client needs across varying stages of development. The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.

The MWS Consultant I position is eligible for remote work based on company requirements, with no minimum in-office requirement.

Key Responsibilities

• 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.

Qualifications

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
• RAC certification is beneficial.

Requirements

• 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.
• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
• Effective written and verbal communication skills, with the ability to communicate complex scientific and regulatory information clearly and concisely.
• Exceptional project and time management skills, with the ability to prioritize multiple projects and adjust timelines proactively.
• Patient and empathetic approach, especially in cross-cultural and client-facing environments.
• Positive attitude toward feedback and a willingness to apply it for continuous improvement.
• Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements.
• High attention to detail, ensuring alignment and accuracy across multiple document reviews.

Essential Functions

• Physical demands include regular use of a computer keyboard and mouse; reaching with hands and arms; talking and listening.
• Frequent walking and sitting, as well as lifting and carrying objects such as books and files weighing up to 25 pounds.
• Occasional standing, stooping, or kneeling.
• Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment

• Moderate noise level.
• Indoor temperate environment.
• Light levels that are bright and conducive to minimal eye strain, typical for an office environment.