Senior Medical Writing Director — Hybrid/Remote

ProPharma; Raleigh (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

ProPharma is seeking a senior medical writing/quality control leader to drive departmental growth, improve processes, and lead cross-functional coordination in a hybrid setup. The role emphasizes client relationship management and strategic capability development within regulatory frameworks.

The ideal candidate has 7+ years in medical writing/QA for drugs, biologics, or devices, plus 5+ years in project/resource management, and a strong track record in business development and mentoring teams.

Qualifications

• Bachelor’s degree or higher, preferably in medical or scientific discipline.
• Minimum of 7 years of experience in writing/quality control review of clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.
• Minimum of 5 years of experience in project and resource management.

Responsibilities

• Contributes to departmental growth by cross-functional development/improvement of medical writing/quality control processes to ensure high quality, uniform, complete deliverables.
• Leads medical writing business development efforts (capabilities meetings, bids/contracts, proposal development, budget review, and bid defenses).
• Organizes and leads departmental initiatives (e.g., process improvement, lunch and learns).
• Defines and manages medical writing and quality control resource needs, and communicates with recruiting and business development.
• Maintains communication on project- and program-related matters with medical writing leadership and internal stakeholders.
• Manages documents for assigned clients, including protocols, amendments, IBs, ICFs, and complex submissions.
• Provides project management oversight to develop and maintain client relationships and deliverables.
• Leads cross-functional coordination of resources to manage deliverables.
• Manages direct reports to ensure on-time, in-budget completion.
• Performs manager/peer review of documents; mentors less experienced writers/editors.
• Authors high-quality medical writing deliverables across clinical, regulatory, device, and diagnostics areas.
• Adheres to regulatory standards including ICH E3/E6, EU MDR/IVDR, templates.
• Ensures accurate billing of time and reviews accruals/invoices.
• Other duties as assigned.

Skills

Leadership

Regulatory knowledge

FDA regulations

Project management

Budgeting

Communication

AMA style

Client relations

Process improvement

Travel readiness

Education

Bachelor's degree or higher in medical/scientific

Tools

MS Word

Job description

ProPharma is seeking a senior medical writing/quality control leader to drive departmental growth, improve processes, and lead cross-functional coordination in a hybrid setup. The role emphasizes client relationship management and strategic capability development within regulatory frameworks.

The ideal candidate has 7+ years in medical writing/QA for drugs, biologics, or devices, plus 5+ years in project/resource management, and a strong track record in business development and mentoring teams.