Manager/Associate Director, Medical Writing - Regulatory

About This Role

This role involves project-specific management of medical writing staff, ensuring quality standards and adherence to Sponsor objectives in regulatory medical writing deliverables. An Associate Director will also support the medical writing leadership team in strategic planning and business updates.

Responsibilities

• Manage project-specific medical writing staff members, including salary administration, interviewing, selection, and performance appraisals.
• Review and edit departmental work products for completeness, accuracy, and overall quality.
• Ensure adherence to Sponsor objectives and maintenance of quality standards.
• Support the company’s Medical Writing leadership team in planning, development, and implementation of document development strategies.
• Assist with the preparation of budgets and timelines for medical writing activities.
• Contribute to departmental metrics by assisting in tracking, maintaining, 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, addressing issues as they arise.
• Review performance of medical writing personnel (direct reports).
• Develop and maintain departmental SOPs and templates, acting as a resource for implementation.
• Participate in the planning, writing, and assembly of medical writing deliverables.
• Perform senior reviews of medical writing deliverables, statistical analysis plans, and table/figure/listing.

Benefits