Manager/Associate Director, Medical Writing - Regulatory

About This Role

This role involves managing medical writing staff, ensuring the quality and adherence to sponsor objectives for all departmental work products. It also supports the medical writing leadership team in strategic planning and business development activities.

Responsibilities

• Manage project-specific responsibilities for medical writing staff members.
• Recommend courses of action on salary administration, interviewing, selection, terminations, and professional development.
• Review and edit departmental work products for completeness, accuracy, and overall quality.
• Ensure adherence to Sponsor objectives and maintain quality standards.
• Support the company’s MW leadership team in planning, developing, and implementing document development strategies.
• Assist with the preparation of budgets and timelines for medical writing activities.
• Assist with budgeting, revenue, invoicing, and forecasting as requested.
• Contribute to departmental metrics by assisting in tracking and reviewing project metrics.
• Support business development by assisting with proposal and costing development, bid defenses, and customer meetings.
• Build and maintain relationships with internal and external customers.
• Form, maintain, and lead productive cross-functional working teams.
• Review performance of medical writing personnel (direct reports).
• Develop and maintain departmental SOPs and templates and act as resource for implementation.
• Participate in the planning, writing, and assembly of medical writing deliverables, as needed.
• Perform senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing.

Benefits