Manager/Associate Director, Medical Writing – Regulatory

Role Overview

• Project-specific management responsibilities for medical writing staff members
• Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling
• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods
• Reviews and edits departmental work products for completeness, accuracy, and overall quality
• Ensures adherence to Sponsor objectives and that quality standards are maintained
• Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates
• Assists with the preparation of budgets and timelines for medical writing activities
• Assists with budgeting, revenue, invoicing, and forecasting as requested
• Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics
• Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings
• Builds and maintain relationships with internal and external customers
• Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise
• Reviews performance of medical writing personnel (direct reports)
• Develops and maintains departmental SOPs and templates and acts as resource for implementation
• Participates in the planning, writing, and assembly of medical writing deliverables, as needed
• Performs senior reviews of medical writing deliverables

Requirements

• Project-specific management responsibilities for medical writing staff members
• Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling
• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods
• Reviews and edits departmental work products for completeness, accuracy, and overall quality
• Ensures adherence to Sponsor objectives and that quality standards are maintained
• Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates
• Assists with the preparation of budgets and timelines for medical writing activities
• Assists with budgeting, revenue, invoicing, and forecasting as requested
• Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics
• Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings
• Builds and maintain relationships with internal and external customers
• Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise
• Reviews performance of medical writing personnel (direct reports)
• Develops and maintains departmental SOPs and templates and acts as resource for implementation
• Participates in the planning, writing, and assembly of medical writing deliverables, as needed
• Performs senior reviews of medical writing deliverables

Tech Stack

• Assembly

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time