Title: ICF Medical Writing Program Manager
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Medical Writing – Remote
Company Overview:
PPD® Clinical Research Services, part of Thermo Fisher Scientific, is a global leader in clinical trials and drug development. Our teams bring scientific and clinical expertise to accelerate the development of life-changing therapies. As a trusted CRO, we deliver innovative solutions across laboratory, digital, and decentralized clinical trial services, helping clients achieve operational excellence and regulatory compliance.
Role Overview:
We are 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 involves high client engagement, program oversight, and team mentorship. The ideal candidate will manage timelines, budgets, and deliverables for complex projects while ensuring regulatory compliance and quality standards.
Key Responsibilities:
Lead and manage ICF medical writing programs from planning through delivery.
Develop project timelines, standards, budgets, forecasts, and contract modifications.
Serve as a primary point of contact for client interactions and escalations.
Collaborate with cross-functional teams to meet project deliverables, ensuring high-quality output.
Monitor project progress, manage risks, and resolve issues related to timelines, budgets, or quality.
Mentor and train junior staff on program management processes and technical aspects of ICF projects.
Ensure compliance with global, regional, and local regulatory and document development guidelines.
Support business development by preparing proposals, budgets, presentations, and participating in client meetings.
Manage performance metrics for assigned projects and contribute to departmental performance tracking.
Qualifications & Experience:
Bachelor’s degree (scientific discipline preferred) with 8+ years of relevant experience, or advanced degree with 6+ years of relevant experience.
Proven experience managing medical writing or clinical projects in the pharmaceutical/CRO industry.
Experience with regulatory and/or plain language medical writing preferred.
Strong knowledge of global, regional, and national regulatory guidelines for patient-centric documents.
Skills & Competencies:
Advanced project management skills, including budgeting, forecasting, and resource allocation.
Exceptional planning, organizational, and prioritization abilities.
Strong interpersonal, problem-solving, and decision-making skills; self-motivated and adaptable.
Excellent oral and written communication, presentation, and negotiation skills.
Ability to mentor and lead junior staff effectively.
High level of independence and sound judgment in project and program decisions.
Why Join Us:
Work remotely with a global CRO leader in clinical research and medical writing.
Lead complex, patient-focused medical writing programs with high visibility.
Collaborate with experts across clinical, regulatory, and project management teams.
Opportunity to mentor junior team members and influence process improvements.
Equal Opportunity Employer:
Thermo Fisher Scientific is committed to a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other legally protected status.
Apply Now: Join as an ICF Medical Writing Program Manager and advance your career in global clinical research and patient-focused document management.
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