Program Manager Medical Writing

Work Schedule

Environmental Conditions

Job Description

Purpose:

Leads client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management. Manages client relationships and identifies and resolves client management issues. Manages and ensures the timely delivery and the quality of multiple program documents. Develops, monitors, and adapts project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. Serves as subject matter expert for assigned programs.

Essential Functions:

• Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.

• Assists 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.

• Serves as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.

• Ensures 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.

• Provides 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

Qualifications:

Education and Experience:

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