Program Manager, Regulatory Medical Writing

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Create project timelines, standards, budgets, forecasts, and contract modifications for designated projects.

• Act as a liaison with other departments regarding contract modifications.

• Support business development and senior management in securing new business at the program level by preparing and delivering presentations to clients, leading the creation and review of proposal texts and budgets, and aiding in contract negotiations.

• Function as the primary contact for risk escalation concerning assigned programs.

• Assess and appropriately escalate or resolve risks related to project quality, budget, or timeline.

• Ensure adherence to quality processes and requirements for assigned programs, both within and across documents associated with a project.

• Develop, review, and manage performance metrics for the projects assigned.

• Provide training to medical writers regarding processes and technical aspects of program management.

• May take on the role of a backup medical writer, which could involve researching, writing, and editing clinical study reports and protocols, summarizing data from clinical studies, crafting or contributing to complex clinical and scientific documents such as IBs, INDs, and MAAs, and offering senior review of project materials.

⛳️ Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; an advanced degree is preferred.

• Prior experience providing the knowledge, skills, and abilities needed to perform the job (approximately 8+ years).

• Required experience in managing and directing complex medical writing projects.

• Preferred experience in the pharmaceutical/CRO industry.

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

• Strong program management skills, including budgeting, forecasting, and resource management.

• Extensive understanding 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.

• Exceptional negotiation skills.

• Self-motivated and adaptable.

• Excellent judgment with a high degree of independence in decision-making and problem-solving.

• Ability to mentor and lead junior-level staff.

🏝️ Benefits

• 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 integral to the daily experience—and where your contributions truly make a difference.

• Accessibility/Disability Access: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.