Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

Purpose:
Leads patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs), often requiring a high degree of client engagement and management. With a high degree of visibility, manages client relationships and identifies and resolves client management issues. Manages and ensures the timely delivery and the quality of complex programs of documents for internal and external clients. Develops, monitors, and adapts project plans, client and program-specific processes, timelines, and budgets/forecasting for assigned projects. Serves as a subject-matter expert and mentors junior staff.
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. May serves as point of contact for risk escalation for projects managed by junior staff.
• 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. May support management of performance metrics at the department level.
• 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
• Provides training for ICF project managers on processes and technical aspects of program management

Qualifications:
Education and Experience:

• BS/BA (scientific discipline preferred) with at least 8 years relevant experience or an advanced degree with at least 6 years relevant experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Experience in managing medical writing or clinical projects required.
Experience working in the pharmaceutical/CRO industry required.
Experience in medical writing (eg, Regulatory and/or plain language) preferred.
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:
Advanced project management skills, to include budgeting, forecasting, and resource management.
Expert 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
Expert oral and written communication skills with internal and external stakeholders; advanced negotiation skills
In-depth knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables.
Excellent judgment; high degree of independence in decision making and problem solving
Capable of mentoring and leading junior level staff

Skills Required