Remote Principal Medical Writer – Regulatory Submissions

Ladders; United States; Remote; USD 114,000 - 211,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits including medical, and

401k company match

Employee Stock Purchase Plan

Commissions and bonuses based on perf.

Flexible PTO and sick time

Job summary

Ladders is seeking a Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview) to join our team in a remote US-based role. You will create high-quality regulatory documents for global filings, coordinating with cross-functional teams to ensure accuracy, compliance, and submission readiness.

The position also supports process improvements across the organization. Candidates should have a Bachelor's degree (advanced degree preferred) and at least 5 years of medical

Qualifications

• Bachelor's degree required; advanced degree preferred in a relevant field.
• Minimum 5 years of medical writing experience in biopharmaceutical, CRO, or comparable development.
• Excellent verbal and written communication skills.
• Strong organizational, time management, and project management abilities.
• Knowledge of global regulatory requirements and therapeutic areas in clinical development is desirable.

Responsibilities

• Develop regulatory documents for global submissions aligned with ICH and client standards.
• Manage medical writing projects, timelines, and cross-functional communication.
• Participate in cross-functional meetings to discuss deliverables and processes.
• Review protocols and statistical analysis plans as needed.
• Engage in cross-functional process improvement initiatives.
• Define and write standard operating procedures for efficient document prep.
• Mentor junior medical writing staff and manage internal and contract resources.

Skills

Organizational skills

Time management

Project management

Verbal and written communication

Interpersonal communication

Education

Bachelor's degree

Advanced degree preferred

Tools

MS Word

Electronic document management systems

Job description

Ladders is seeking a Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview) to join our team in a remote US-based role. You will create high-quality regulatory documents for global filings, coordinating with cross-functional teams to ensure accuracy, compliance, and submission readiness.

The position also supports process improvements across the organization. Candidates should have a Bachelor's degree (advanced degree preferred) and at least 5 years of medical