Program Manager, Regulatory Medical Writing

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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.

🎯 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. • 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 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.

🏖️ 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 part of the everyday 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.