ICF Medical Writing Program Manager
📍 Location: Remote, India
🆔 Job ID: R-01332284
💼 Job Type: Full-time
🏢 Category: Clinical Research
🌐 Work Mode: Fully Remote
🕒 Work Schedule: Standard (Monday–Friday)
🏠 Environment: Office / Remote
About the Role
The ICF Medical Writing Program Manager leads patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs). This role involves managing complex client relationships, ensuring timely and high-quality document delivery, and leading cross-functional teams in a global clinical research environment. The position requires both scientific expertise and strategic project management capabilities.
Key Responsibilities
Program & Project Management
Lead the planning, execution, and delivery of ICF medical writing programs.
Develop and oversee project timelines, budgets, forecasts, and contract modifications.
Coordinate across departments to ensure deliverables meet quality, time, and budget requirements.
Monitor progress through tracking and management tools; provide status updates and escalate risks when necessary.
Ensure all assigned projects comply with quality standards, processes, and regulatory requirements.
Client Relationship & Business Development
Act as a primary liaison for client engagement, managing expectations and resolving issues.
Support business development efforts by preparing and presenting proposals, budgets, and program plans.
Lead client meetings and identify opportunities for expanding partnerships.
Risk & Quality Oversight
Evaluate and mitigate risks impacting project quality, budget, or timelines.
Review and manage project performance metrics, escalating issues when appropriate.
Support audit readiness and ensure consistency across program deliverables.
Leadership & Mentorship
Mentor and train junior staff and new project managers in medical writing and program management.
Provide guidance on best practices, compliance, and quality assurance in ICF development.
Qualifications
Education
Bachelor’s degree (BS/BA) in a scientific discipline (e.g., Life Sciences, Pharmacy, Biochemistry) with 8+ years of relevant experience, OR
Advanced degree (MS/PhD) with 6+ years of relevant experience.
Experience
Proven experience in medical writing program management or clinical project management.
Prior experience in the pharmaceutical or CRO industry is required.
Experience in Regulatory or Plain Language medical writing preferred.
Knowledge, Skills & Abilities
Advanced project management skills including budgeting, forecasting, and resource allocation.
Strong organizational and prioritization abilities to manage multiple complex projects.
Excellent communication and negotiation skills with both internal and external stakeholders.
Deep understanding of global regulatory and documentation guidelines for patient-centric deliverables.
High level of independence, problem-solving ability, and decision-making.
Ability to mentor and lead junior-level team members effectively.
Gujarat :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Japan | Saitama |Tokyo :
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