FSP Program Manager – Medical Writing

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee client programs that are prominently visible to both internal and external teams.

• Cultivate and manage client relationships while addressing and resolving any client management challenges.

• Ensure the timely delivery and quality of various program documents.

• Create, track, and adjust project plans, as well as client-specific processes, timelines, and budgets/forecasts.

• Act as a subject matter expert for designated programs.

• Develop project timelines, standards, budgets, forecasts, and modifications to contracts.

• Collaborate with other departments regarding contract modifications.

• Assist business development and senior management in acquiring new business at the program level.

• Create and present client presentations.

• Lead the development and review of proposal texts and budgets.

• Support contract negotiations.

• Function as a point of contact for risk escalation and assess, escalate, or resolve risks affecting project quality, budget, or schedule.

• Ensure adherence to quality processes and requirements across all assigned programs and project documents.

• Develop, review, and manage performance metrics.

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

• May act as a backup medical writer, which includes researching, writing, and editing clinical study reports and protocols.

• Summarize data derived from clinical studies.

• Write or contribute to complex clinical and scientific documents such as IBs, INDs, and MAAs.

• Provide senior-level review of project materials.

⛳️ Requirements

• Bachelor's degree in a scientific field or an equivalent and relevant formal academic/vocational qualification.

• An advanced degree is preferred.

• A minimum of 8 years of prior experience that provides the knowledge, skills, and abilities necessary for the role.

• 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.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be considered.

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

• Comprehensive knowledge of global, regional, national, and other document development guidelines.

• Extensive knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.

• Exceptional interpersonal, oral and written communication, and presentation abilities.

• Outstanding negotiation skills.

• Self-motivated and adaptable.

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

• Capable of mentoring and leading junior staff members.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and make meaningful breakthroughs.