FSP Program Manager – Medical Writing

• Lead client programs with high visibility among internal and client teams
• Manage client relationships and identify and resolve client management issues
• Manage and ensure the timely delivery and quality of multiple program documents
• Develop, monitor, and adapt project plans, client- and program-specific processes, timelines, and budgets/forecasting
• Serve as subject matter expert for assigned programs
• Develop project timelines, standards, budgets, forecasts, and contract modifications
• Liaise with other departments on contract modifications
• Support business development and senior management in securing new program-level business
• Develop and deliver client presentations
• Lead development and review of proposal texts and budgets
• Support contract negotiations
• Serve as point of contact for risk escalation
• Evaluate and escalate or resolve risks to project quality, budget, or timeline
• Ensure compliance with quality processes and requirements within and between project documents
• Develop, review, and manage performance metrics
• Provide training for medical writers on processes and technical aspects of program management
• May serve as backup medical writer by researching, writing, and editing clinical study reports and protocols
• Summarize clinical study data
• Write or provide input on complex clinical and scientific documents such as IBs, INDs, and MAAs
• Provide senior review of project materials

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Experience in managing and directing complex medical writing projects
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Solid program management skills, including 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, or communications
• Excellent interpersonal, oral and written communication, and presentation skills
• Excellent negotiation skills
• Self-motivated and adaptable
• Excellent judgment and a high degree of independence in decision making and problem solving
• Capable of mentoring and leading junior-level staff
• Equivalency may consist of a combination of appropriate education, training, and/or directly related experience

• Collaboration and development opportunities
• Opportunity to work as part of a global team
• Opportunity to contribute to scientific excellence and meaningful breakthroughs