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Senior ICF Project Manager
Thermo Fisher Scientific. Lead patient-centric medical writing projects with a primary focus on informed consent forms (ICFs) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading patient-centric medical writing projects, particularly in developing informed consent forms, while effectively managing project timelines, budgets, and resources. Strong ability to collaborate with cross-functional teams and ensure compliance with regulatory guidelines.
Highest-signal resume keywords
Medical Writing ManagementProject Management SkillsInformed Consent Form DevelopmentPharmaceutical/CRO Industry ExperienceRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementBudgetingForecastingResource ManagementMedical WritingRegulatory WritingPlain Language WritingProject Performance MetricsRisk EvaluationTimeline Monitoring
Soft Skills
Interpersonal SkillsProblem-SolvingJudgmentDecision-MakingNegotiation Skills
Tools & Technologies
Tracking ToolsManagement Tools
Industry Keywords
Patient-Centric DeliverablesClinical ProjectsCross-Functional CollaborationClient Relationship ManagementQuality Processes
About the role
Key responsibilities & impact- Lead patient-centric medical writing projects with a primary focus on informed consent forms (ICFs)
- Collaborate with internal and client teams
- Manage project timelines, budgets, and resources
- Ensure timely delivery and quality of projects and documents for internal and external clients
- Build client relationships and identify and resolve client management issues
- Develop, monitor, and adapt project plans, timelines, budgets, and forecasts
- Develop project standards and contract modifications and liaise with other departments
- Collaborate with cross-functional teams and lead team meetings
- Prepare and monitor timelines and provide status updates
- Review projects using tracking and management tools
- Evaluate, escalate, or resolve risks to project quality, budget, or timeline
- Ensure compliance with quality processes and requirements
- Review and manage project performance metrics
Requirements
What you’ll need- 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 providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years
- Experience managing medical writing or clinical projects required
- Experience managing ICF content advantageous
- Experience working in the pharmaceutical/CRO industry preferred
- Experience in medical writing, including regulatory and/or plain language, advantageous
- Strong project management skills, including budgeting, forecasting, and resource management
- Solid planning and organizational skills
- Excellent interpersonal, problem-solving, judgment, and decision-making skills
- Effective oral and written communication skills with internal and external stakeholders
- Strong negotiation skills
- Knowledge of global, regional, national, and other regulatory and document development guidelines relevant to patient-centric deliverables
- High degree of independence in decision-making and problem-solving
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment