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.

• 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 the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position 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, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.