Director, Medical Writing

HW3; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Hw3 Llc in the United States is seeking an experienced Medical Writing leader to support multiple clinical development programs, regulatory submissions, and the continued growth of the function. The role combines hands-on authoring with leadership duties, overseeing regulatory documents and liaising with Clinical Development, Regulatory Affairs, and external vendors to ensure timely, compliant submissions.

Ideal candidate will drive process improvements and mentor junior writers while managing

Qualifications

• Strong scientific background with extensive clinical and regulatory Medical Writing experience.
• Significant in house Medical Writing experience within biotech or pharmaceutical organizations.
• Experience supporting clinical development programs and regulatory submissions.
• Previous people management or team leadership experience.

Responsibilities

• Lead hands on authoring and development of clinical and regulatory documents across multiple programs.
• Support regulatory submissions, including INDs and NDAs, and post approval activities.
• Partner cross functionally with Clinical Development, Regulatory Affairs, and external writing vendors.
• Optimize Medical Writing processes, workflows, and standards.
• Take on increasing leadership and oversight responsibilities as the team expands.

Skills

Medical Writing

Regulatory Submissions

Leadership/People Management

Cross-functional Collaboration

Clinical Development Knowledge

Education

Advanced degree in life sciences (PhD/MD/MS)

Job description

Biotechnology | Clinical & Regulatory Writing

Partnering with a biotechnology organization preparing to expand its in house Medical Writing team. This is an opportunity for an experienced Medical Writing leader to support multiple clinical development programs, regulatory submissions, and the continued growth of the function.

Key Responsibilities

• Lead hands on authoring and development of clinical and regulatory documents across multiple programs.
• Support regulatory submissions, including INDs and NDAs, and post approval activities.
• Partner cross functionally with Clinical Development, Regulatory Affairs, and external writing vendors.
• Optimize Medical Writing processes, workflows, and standards.
• Take on increasing leadership and oversight responsibilities as the team expands.

Ideal Background

• Strong scientific background with extensive clinical and regulatory Medical Writing experience.
• Significant in house Medical Writing experience within biotech or pharmaceutical organizations.
• Demonstrated experience supporting clinical development programs and regulatory submissions.
• Previous people management or team leadership experience.
• Comfortable working in a lean, fast paced environment with significant hands on writing responsibilities.
• Flexible, adaptable, and capable of supporting programs across different stages of development.