Program Manager, Regulatory Medical Writing – Client-dedicated FSP

About This Opportunity

We are representing a confidential clinical research organization seeking a Program Manager, Regulatory Medical Writing to join their client-dedicated functional service provider team. This is a remote position based in the United States.

Our client supports pharmaceutical and biotech companies worldwide, managing complex clinical trials and regulatory submissions. In this senior leadership role, you will oversee multiple regulatory writing programs with high client visibility, ensuring operational excellence and timely delivery of critical regulatory documents.

Responsibilities

• Lead client programs requiring significant stakeholder engagement and management across internal and external teams
• Develop and monitor project timelines, budgets, forecasts, and program-specific processes for multiple concurrent deliverables
• Serve as primary point of contact for risk escalation, evaluating and resolving issues related to project quality, budget, or timeline
• Ensure compliance with quality processes and manage performance metrics across assigned programs
• Coordinate with cross-functional departments on contract modifications and serve as liaison for program needs
• Support business development efforts through client presentations, proposal development, and budget planning
• Provide training and mentorship to medical writers on program management processes and technical requirements
• May serve as backup medical writer for clinical study reports, protocols, investigator brochures, INDs, and marketing authorization applications

What We're Looking For

Required Qualifications:

• Bachelor's degree in a scientific discipline (advanced degree preferred)
• 8+ years of relevant experience demonstrating progressive responsibility
• Proven experience managing and directing complex medical writing projects
• Strong program management skills including budgeting, forecasting, and resource allocation
• Extensive knowledge of global, regional, and national document development guidelines
• In-depth expertise in one or more specialty areas: preclinical, therapeutic, regulatory submissions, or scientific communications
• Excellent interpersonal, written, and oral communication skills with strong presentation abilities
• Self-motivated with excellent judgment and high degree of independence in decision-making
• Capability to mentor and lead junior-level staff

Preferred Qualifications:

• Experience in the pharmaceutical or CRO industry
• Professional certifications in medical writing (AMWA, EMWA, or RAC)

How We Work With You

Candidates interested in this position should apply directly through Get A Job.ai. Our talent team will conduct an initial screening to ensure alignment with the role requirements. Qualified candidates will then be submitted to our client for consideration. Please do not contact the client directly—all communication and coordination will be managed through our recruiting team at Get A Job.ai.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Opportunity: Get A Job.ai is committed to providing equal employment opportunities to all applicants regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic under applicable law.