Program Manager Medical Writing
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Job Location:
Monthly Salary:
Posted on:
02-11-2025
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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:
Bachelors 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
Required Experience:
Manager
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
About Company
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