Director, Medical Writing

TL;DR

Director, Medical Writing (Pharma/Biotech): Lead medical writing and quality control for clinical and regulatory documents across product lifecycle with an accent on complex submissions like IND/NDA/BLA and departmental growth. Focus on managing teams, business development, cross-functional coordination, and ensuring compliance with FDA/ICH standards.

Location: United States, remote supported with hybrid encouraged for those near offices

Company

Consulting firm providing end-to-end solutions for biotech, med device, and pharma across regulatory sciences, clinical research, quality, pharmacovigilance, and R&D technology.

What you will do

• Lead medical writing business development including proposals, bids, and client meetings.
• Manage medical writing programs, resources, and deliverables for clients like protocols, IBs, study reports, and regulatory submissions (IND, NDA, BLA, MAA).
• Oversee direct reports, perform reviews, mentor writers, and coordinate cross-functionally.
• Drive departmental initiatives, process improvements, and resource planning.
• Author/edit high-quality documents as needed across clinical phases and therapeutic areas.
• Ensure accurate billing, compliance with standards, and effective communication.

Requirements

• United States based preferred for hybrid near offices.
• Bachelor’s degree or higher, preferably in medical/scientific discipline.
• Minimum 7 years experience in clinical/regulatory document writing/review for drugs/biologics/devices in CRO/pharma/biotech.
• Minimum 5 years in project/resource management.
• Expert knowledge of clinical research, FDA regulations, and submission processes.
• Advanced MS Word skills, leadership, communication, and business development abilities.
• English proficiency with AMA style; occasional travel (valid passport).

Culture & Benefits

• Hybrid/remote flexibility, with in-person collaboration encouraged near offices.
• Diversity, equity, inclusion focus; authentic self encouraged.
• Innovative, collaborative, entrepreneurial environment.
• Personal review of applications, no AI screening; always receive outcome.

Hiring process

• All applications personally reviewed by recruitment team.
• Outcome provided for every application.