Consultant I, Medical Writing

About the Company

Syner-G enables people to build careers that positively impact their quality of life. We accelerate breakthrough science and deliver life-enhancing therapies to more patients through expertise, consulting, and management across diverse clients and projects. Our work spans critical phases of drug discovery, approval, and commercialization, offering meaningful, varied, and thought-provoking opportunities with real-world outcomes. Recently honored with BioSpace's "Best Places to Work" 2026 award for the third consecutive year, Syner-G fosters a culture of growth, learning, and reward, aligning with our mission to be a strategic biopharma partner globally.

About the Role

The MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables aligned with client expectations and regulatory standards. This position leads document development, coordinates regulatory projects, and collaborates with cross-functional teams to meet diverse client needs across varying stages of development. The role serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships.

This position is eligible for remote work with no minimum in-office requirement.

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.

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 of 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.

Skills

• 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

The physical demands described here are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen.
• Frequently required to walk and sit, as well as lift and carry objects such as books and files weighing up to 25 pounds.
• Occasionally required to stand, stoop, or kneel.
• Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Moderate noise level, indoor temperate environment, and light levels bright and conducive to minimal eye strain, typical for an office environment.

Benefits

Syner-G's Total Rewards Program includes:

• Market-competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program, company-paid holidays, and flexible working hours.
• Fully remote or hybrid work options for some roles.
• Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
• Ongoing recognition and career development opportunities.