Consultant I, Medical Writing

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 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.

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 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; 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.

Benefits

Our total rewards program includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote or hybrid work options for some roles. However, if a physical work location is more suitable, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Pay

Market competitive base salary and annual incentive plan.

Schedule

Full time, remote work eligibility based on company requirements.