Job Details

Medical Writing Project Lead

Leads patient-centric medical writing projects with a primary focus on Informed Consent Forms (ICFs) through collaboration with internal and client teams. Manages project timelines, budgets, and resources. Manages and ensures the timely delivery and the quality of individual projects and documents for internal and external clients. Builds client relationships and identifies and resolves client management issues. Develops, monitors, and adapts project plans, timelines, and budgets/forecasting for assigned projects.

Essential Functions:

• Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
• Collaborates with cross-functional team members as needed to meet the deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, and quality are maintained.
• Ensures achievement of final deliverables within the contractual time period by preparing and monitoring timelines, providing status updates to the appropriate point of escalation, and regularly reviewing projects using tracking and management tools.
• Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
• Ensures compliance with quality processes and requirements for assigned projects both within and between documents within a project. Reviews and manages performance metrics for assigned projects.

Qualifications:

Education and Experience:

BS/BA (scientific discipline preferred) with at least 5 years relevant experience or an advanced degree with at least 3 years relevant experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Experience in managing medical writing or clinical projects required.

Experience working in the pharmaceutical/CRO industry preferred.

Experience in medical writing (eg, Regulatory and/or plain language) advantageous.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Strong project management skills, to include budgeting, forecasting, and resource management.

Solid planning and organizational skills to enable effective prioritization of workload.

Excellent interpersonal skills, including problem solving, judgment, and decision-making skills; self-motivated and adaptable

Effective oral and written communication skills with internal and external stakeholders; strong negotiation skills

Good knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables.

Good judgment; high degree of independence in decision making and problem solving.