Director, Medical Writing

Barrington James; United States; On-site; USD 110,208 - 137,760; Full time

Job summary

A healthcare recruitment company is seeking a highly motivated and experienced medical writer for a leadership role. This position involves strategic planning and the delivery of high-quality clinical and regulatory documents supporting global drug development. Candidates should have 8+ years of experience in medical writing, strong knowledge of regulatory requirements, and project management skills. This is a contract position based in the United States.

Qualifications

• 8+ years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
• Strong knowledge of global regulatory requirements (FDA, ICH, EMA).
• Experience mentoring junior writers or managing vendors preferred.

Responsibilities

• Lead the development and delivery of clinical and regulatory documents.
• Ensure scientific accuracy, consistency, and alignment with regulatory strategy.
• Mentor and manage in-house and contractor medical writers.

Skills

Medical writing

Project management

Communication skills

Education

Advanced degree in life sciences (PhD, PharmD, or MS)

Tools

MS Word

Document management systems

Electronic submission tools

Job description

Base pay range

$80.00/hr - $100.00/hr

Recruitment Consultant @ Barrington James | Medical communications / Medical Affairs

I am looking for a highly motivated and experienced medical writer

This is a leadership role; you will be responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs.

Key Responsibilities

• Lead the development and delivery of clinical and regulatory documents (e.g., CSRs, IBs, DSURs, FDA briefing documents) in compliance with ICH guidelines and regulatory requirements.
• Ensure scientific accuracy, consistency, and alignment with regulatory strategy.
• Collaborate with cross-functional teams (Clinical, Regulatory, Biostatistics, Pharmacovigilance, etc.) to gather information and align timelines.
• Mentor and manage in-house and contractor medical writers to ensure quality deliverables.
• Contribute to the development of SOPs, templates, and style guides.
• Support regulatory submission planning and assist in vendor selection and management.

Qualifications

• Advanced degree in life sciences (PhD, PharmD, or MS preferred).
• Background in scientific writing.
• 8+ years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
• Strong knowledge of global regulatory requirements (FDA, ICH, EMA).
• Excellent project management and communication skills.
• Experience with MS Word, document management systems, and electronic submission tools.
• Proven experience with clinical study protocols, CSRs, IBs, DSURs, and regulatory submissions (INDs, FDA briefing documents).
• Experience mentoring junior writers or managing vendors preferred.

Seniority level

• Director

Employment type

• Contract

Job function

• Science