Senior ICF Med Writing Project Manager/ICF Program Manager

Thermo Fisher Scientific • Morrisville, NC

1d • Onsite

About The Position

Join Us as Senior ICF Medical Writing Project Manager/ICF Program Manager – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As an ICF Program Manager, you will lead patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs), collaborating with internal and client teams while maintaining a high degree of client engagement and management. You will manage project timelines, budgets, and resources, ensuring the timely delivery and quality of complex programs of documents for internal and external clients. You will build client relationships and identify and resolve client management issues. Additionally, you will develop, monitor, and adapt project plans, client- and program-specific processes, timelines, and budgets/forecasting for assigned programs. You will also serve as a subject matter expert and mentor junior staff.

Requirements

• 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 clinical or medical writing (or similar) projects required.
• Experience working in the pharmaceutical/CRO industry required.
• 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.

Nice To Haves

• Experience in ICF content and customization (eg, Regulatory and/or plain language) preferred.
• 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.

Responsibilities

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serve as liaison with other departments on contract modifications.
• Collaborate with cross-functional team members as needed to meet the deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, and quality are maintained.
• Ensure 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 review projects using tracking and management tools.
• Evaluate and appropriately escalate or resolve risks to project quality, budget, or timeline. Serve as a point of contact for risk escalation for programs managed by junior staff.
• Ensure compliance with quality processes and requirements for assigned programs both within and between documents. Review and manage performance metrics for assigned programs, and support management of department-level performance metrics as needed.
• Assist 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.
• Provide training for ICF project managers on processes and technical aspects of program management.
• Support business development activities by partnering with senior management to secure new business through client presentations, proposal development, budget preparation, and contract negotiations.
• Serve as a subject matter expert by providing guidance, mentoring, and training to ICF Project Managers on program management processes and best practices.

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior