Director, Medical Writing

Location: United States. Remote work is supported; employees near an office are encouraged to work on a hybrid basis with manager approval.

Company

hirify.global provides consulting and lifecycle support across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Lead medical writing and quality control initiatives, process improvements, and departmental development.
• Manage complex clinical, safety, regulatory, device, diagnostic, and disclosure documents, including protocols, study reports, IBs, ICFs, PBRERs, INDs, NDAs, BLAs, MAAs, and eCTD submission-level documents.
• Provide project management oversight for client programs, deliverables, budgets, billing, resource allocation, and client relationships.
• Lead business development activities, including capability meetings, proposals, bids, budget reviews, and bid defenses.
• Coordinate internal and external resources and collaborate with medical writing leadership and cross-functional stakeholders.
• Manage, review, supervise, mentor, and coach medical writers and quality control editors.

Requirements

• Minimum 7 years of experience writing or reviewing clinical and/or regulatory documents for drugs, biologics, medical devices, or diagnostics.
• Minimum 5 years of experience in project and resource management.
• Bachelor’s degree or higher, preferably in a medical or scientific discipline.
• Expert knowledge of clinical research principles, clinical data interpretation, regulatory submissions, and FDA and other applicable regulations.
• Advanced MS Word skills, including tables, graphs, and figures, with familiarity with AMA style and English proficiency.
• Strong leadership, communication, problem-solving, negotiation, business development, budgeting, forecasting, and relationship management skills.

Nice to have

• Experience in a contract research organization, pharmaceutical company, or biotechnology company.
• Experience with ICH E3/E6(R2), EU MDR/IVDR, standard operating procedures, and client-approved templates.

Culture & Benefits

• Remote work is supported, with hybrid collaboration encouraged for employees within a reasonable commute of an office.
• Occasional domestic and international travel, including overnight stays, may be required.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, innovation, and entrepreneurship.
• Applications are reviewed personally by the recruitment team without AI screening tools.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.