Position Title: Senior ICF Medical Writing Project Manager
Location: Remote, India
Job ID: R-01331611
Job Type: Full-Time
Category: Clinical Research
Work Arrangement: Fully Remote
Work Schedule: Second Shift (Afternoons)
Environment: Office
Company Overview
Our Clinical Research Services team is at the forefront of bringing life-saving cures to market. As part of our PPD® clinical research portfolio within a leading global CRO, we combine scientific expertise and clinical excellence to address the world’s most challenging health concerns.
Purpose of the Role
The Senior ICF Medical Writing Project Manager leads patient-centric medical writing projects, primarily focusing on Informed Consent Forms (ICFs). This role involves close collaboration with internal teams and clients to ensure high-quality, timely, and compliant deliverables. The position also includes project planning, budgeting, resource allocation, and client relationship management.
Key Responsibilities
Project Management
Develop and manage timelines, standards, budgets, forecasts, and contract modifications for assigned projects.
Serve as a liaison between departments to coordinate contract and project-related discussions.
Monitor project progress, ensuring deliverables are achieved within contractual timelines using tracking and management tools.
Identify and escalate risks related to project quality, budget, or timelines, and implement corrective actions.
Team Collaboration
Lead cross-functional project meetings, ensuring alignment of timelines, resources, and deliverables.
Communicate regularly with internal and client teams to maintain project transparency and efficiency.
Quality & Compliance
Ensure adherence to global and organizational quality processes for all assigned projects.
Review and manage performance metrics and document quality across multiple deliverables.
Qualifications
Education & Experience
Bachelor’s degree (BS/BA) in a scientific discipline preferred, with 5+ years relevant experience,
or Advanced degree (MS/PhD) with 3+ years relevant experience.
Proven experience in medical writing or clinical project management required.
Prior experience in the pharmaceutical or CRO industry preferred.
Familiarity with regulatory and plain-language medical writing is advantageous.
Note: Experience guidelines are indicative and not strict determinants for role eligibility.
Knowledge, Skills, and Abilities
Strong project management skills, including budgeting, forecasting, and resource planning.
Excellent organizational and prioritization abilities.
Effective interpersonal and communication skills—both written and verbal.
Strong problem-solving, decision-making, and negotiation capabilities.
Good understanding of global, regional, and national regulatory requirements for patient-centric documentation.
High level of independence, adaptability, and sound judgment.
Equal Opportunity Statement
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination based on characteristics protected by local, state, or federal law.
Accessibility
We are committed to providing reasonable accommodations for individuals with disabilities in all phases of the employment process. Please contact us if you need assistance during the application or interview process.
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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