Associate Director, Medical Writing

Ladders; United States; Remote; USD 161,000 - 201,000; Full time

Benefits offered by this job

Remote within US

Professional development

Training opportunities

Supportive culture

Impactful work

Job summary

Ladders is seeking an Associate Director, Medical Writing to guide clinical/regulatory content development for drug programs in a highly regulated environment. You will partner with cross-functional teams to shape strategy, governance, and ensure scientific accuracy across documents.

The role emphasizes leadership, process improvement, mentoring, and efficient execution across global regulatory initiatives, with remote US-based eligibility.

Qualifications

• Excellent writing and communication skills.
• Strong understanding of clinical and scientific data interpretation.
• Knowledge of drug development processes and regulatory requirements for GCP/ICH/eCTD documents.
• Experience with NDAs/BLAs and regulatory document preparation.
• Proven project management skills and ability to multitask.

Responsibilities

• Plan, write, edit, and finalize clinical and regulatory documents.
• Provide writing strategy support to cross-functional teams.
• Ensure compliance with medical writing processes and global regulations.
• Collaborate to implement best practices and improve clinical trial execution.
• Create and maintain SOPs and governance documents for medical writing.
• Identify and address compliance or efficiency gaps in processes.
• Mentor and support the development of the medical writing team.

Skills

Writing skills

Communication

Data interpretation

Regulatory knowledge

NDAs/BLAs understanding

Project management

Education

Bachelor's degree in life sciences

Job description

For our client, we are seeking a Associate Director, Medical Writing to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will guide the development of high-quality clinical and regulatory content that supports drug development programs and key submissions in a highly regulated environment. The Associate Director will partner closely with cross-functional stakeholders to shape medical writing strategy, strengthen document governance, and help ensure consistency, compliance, and scientific accuracy across critical deliverables. This position also plays an important leadership role in improving processes, mentoring team members, and supporting efficient execution across global regulatory initiatives.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $160,800 – $201,000 annually

Responsibilities

• Plan, write, edit, and finalize clinical and regulatory documents
• Provide writing strategy support to cross-functional teams
• Ensure compliance with medical writing processes and global regulations
• Collaborate to implement best practices and improve clinical trial execution
• Create and maintain SOPs and governance documents for medical writing
• Identify and address compliance or efficiency gaps in processes
• Mentor and support the development of the medical writing team

Qualifications

• Bachelor's degree in life sciences preferred
• 10+ years of relevant experience, including 8+ years in medical writing
• Excellent writing and communication skills
• Strong understanding of clinical and scientific data interpretation
• Knowledge of drug development processes and regulatory requirements for GCP/ICH/eCTD documents
• Experience with NDAs/BLAs and regulatory document preparation
• Proven project management skills and ability to multitask

Benefits

• Fully remote work opportunity within the U.S.
• Participation in cross-functional teams and global regulatory initiatives
• Opportunities for professional development and training
• Supportive work culture emphasizing kindness and integrity
• Engagement in corporate objectives with significant impact

Our client is an equal opportunity employer.