Program Manager Regulatory Medical Writing

Thermo Fisher Scientific • Morrisville, NC

2d • Onsite

About The Position

Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management; manage client relationships and identify and resolve client management issues; manage and ensure the timely delivery and the quality of multiple program documents; develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. You will also serve as subject matter expert for assigned programs. What You’ll Do:

Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• Experience in managing and directing complex medical writing projects required
• Solid program management skills to include budgeting, forecasting and resource management
• Extensive knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
• Excellent interpersonal, oral and written communication, and presentation skills
• Excellent negotiation skills
• Self-motivated and adaptable
• Excellent judgment; high degree of independence in decision making and problem solving
• Capable of mentoring and leading junior level staff

Nice To Haves

• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Responsibilities

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects.
• Serves as liaison with other departments on contract modifications.
• Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations.
• Serve as point of contact for risk escalation for assigned programs.
• Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
• Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project.
• Develops, reviews and manages performance metrics for assigned projects.
• Provide training for medical writers on processes and technical aspects of program management.
• May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees