Program Manager Medical Writing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 :

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

Employment Type : Full-Time

Experience : years

Vacancy : 1