Regulatory Medical Writing jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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:

• 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.

Education and Experience 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

• Experience working in the pharmaceutical/CRO industry preferred

• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• 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

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.