Consultant I, Medical Writing

Responsibilities

• (This list is not exhaustive and may be supplemented or changed as necessary.)
• 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 AND REQUIREMENTS:
• Education:
• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
• RAC certification is beneficial.
• Technical Experience:
• 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.
• Knowledge, Skills, and Abilities:
• 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.
• Excep

Benefits

Additional Information

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: T he 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. WORK LOCATION: The MWS Consultant I position is eligible for remote work based on company requirements, with no minimum in-office requirement .

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