Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Manager/Associate Director, Medical Writing – Regulatory
Location
Arizona + 3 moreAll locations: Arizona, Maine, Ohio, Rhode Island
Posted
34 days ago
Salary
$95K - $175.7K / year
Seniority
Senior
Job Description
Job 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
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
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