Senior ICF Medical Writing Project Manager / ICF Program Manager

Job not on LinkedIn

🔥 16 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs) • Collaborate with internal and client teams while maintaining a high degree of client engagement and management • Manage project timelines, budgets, and resources, ensuring timely delivery and quality of complex programs of documents for internal and external clients • Build client relationships and identify and resolve client management issues • Develop, monitor, and adapt project plans, client- and program-specific processes, timelines, and budgets/forecasting for assigned programs • 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 • Experience in ICF content and customization (eg, Regulatory and/or plain language) preferred• Advanced project management skills, to include budgeting, forecasting, and resource management • Expert planning and organizational skills to enable effective prioritization of workload • 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.

🏖️ Benefits

• Health and wellbeing support for employees • Opportunity to work in a global team