Consultant I, Medical Writing

POSITION OVERVIEW:

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.

WORK LOCATION:

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

KEY 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. 

• 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.