ICF Medical Writing Program Manager
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Job ID: R-01331608
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking an ICF Medical Writing Program Manager to lead patient-centric medical writing programs, with a primary focus on Informed Consent Forms (ICFs). This role requires strong client engagement, program management expertise, and the ability to deliver high-quality documents on time and within budget.
The Program Manager will oversee complex medical writing projects, provide guidance to junior staff, and serve as a subject-matter expert in ICF development. This position is ideal for experienced professionals seeking to combine medical writing expertise with project leadership in a global, remote environment.
Key Responsibilities
Lead and manage ICF medical writing programs, ensuring timely, high-quality deliverables for internal and external clients.
Develop, monitor, and adjust project plans, timelines, budgets, and forecasts for assigned programs.
Collaborate with cross-functional teams to align on project objectives, deliverables, and resource allocation.
Act as primary liaison with clients, addressing inquiries, managing expectations, and resolving program-related issues.
Monitor and evaluate project risks; escalate issues appropriately to ensure quality, compliance, and timeline adherence.
Maintain compliance with regulatory, global, regional, and client-specific guidelines for medical writing and documentation.
Support business development initiatives by contributing to proposals, presentations, budgets, and contract negotiations.
Provide mentorship and training for junior medical writing staff, sharing best practices and guidance on ICF processes.
Track and report performance metrics for assigned programs, ensuring continuous improvement in project delivery.
Required Qualifications & Experience
Education: BS/BA in a scientific discipline (advanced degree preferred).
Experience:
Minimum 8+ years of relevant experience in medical writing or clinical project management, or 6+ years with an advanced degree.
Proven experience managing medical writing or clinical documentation projects in the pharmaceutical or CRO industry.
Strong knowledge of ICF development, regulatory requirements, and patient-centric communication.
Preferred: Experience in regulatory medical writing, plain language writing, or clinical documentation.
Skills & Competencies
Advanced project management skills, including budgeting, forecasting, and resource allocation.
Excellent planning, organizational, and prioritization skills to manage multiple complex projects.
Strong interpersonal, decision-making, problem-solving, and negotiation skills.
Expert oral and written communication with internal teams and external clients.
In-depth knowledge of global, regional, and national regulatory guidelines relevant to medical writing and patient documents.
Ability to mentor and lead junior staff effectively.
High degree of independence, judgment, and adaptability in dynamic project environments.
Work Schedule & Environment
Standard second shift (afternoons) with flexible remote working options.
Collaborative, global team environment with opportunities to influence patient-centric documentation practices.
Why Join Thermo Fisher Scientific
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Join a global team of experts delivering critical medical writing programs that impact patients worldwide. We value innovation, integrity, collaboration, and diversity, providing opportunities for career growth and professional development.
SEO Keywords Optimized: ICF Medical Writing Jobs Remote India, Program Manager Clinical Research India, Pharmaceutical Medical Writing Careers, Clinical Documentation Jobs Remote, CRO Medical Writing Program Manager.
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