Description
Remote or onsite availability
The Director of Regulatory Writing is a managing professional responsible for the creation of regulatory materials for investigation and marketed products. The individual will also implement and manage regulatory writing projects and supervise Regulatory Writing Specialists in the completion of these projects. The individual also participates in the strategic planning of the Regulatory Writing department.
ESSENTIAL FUNCTIONS
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements
• Leads the Regulatory Writing staff in the development of clinical study protocols, clinical study reports, briefing documents, and IND, NDA, and MAA components across a variety of therapeutic areas and other writing projects.
• Maintains active and ongoing contact with existing clients regarding regulatory and clinical trial project work.
• Acts as a primary writer and/or project manager for key documents and projects.
• Works with global Medical and Regulatory experts to understand, interpret, and apply the clinical considerations and regulatory strategies pertinent to document development.
• Works with clients and internal departments to develop timelines for regulatory writing projects.
• Involved in determining and presenting the scope of work with the business development staff and potential clients when appropriate.
• Supervises the daily activities and performance of the Regulatory Writing Specialists.
• Serves as key contact for communication between the clients and each of the Med Communications teams.
• Supports Quality Assurance activities.
• Takes action to include self-training, creating or revision of new work instructions, or other measures to ensure Med Communications compliance with Client quality guidelines and key performance metrics.
• Identifies, initiates, and monitors to completion, any regulatory and related writing projects.
• Coordinates the work schedule for existing clients, the scheduling of meetings and training sessions, and ensures that all required training requirements are met by all team members.
• Coordinates the schedule of Regulatory Writing Specialists.
• Plans and monitors the resource allocation for team members.
• Provides key input related to the hiring of new Professional Staff.
• Identifies new opportunities for client-related services.
• Supports Business Strategies, including attendance at conferences and travel in the development of new services and sales related to existing services.
