Global Medical Writing Lead: Strategy & Submissions

Regulatory Jobs; Durham (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

IQVIA is seeking an Associate Director of Medical Writing to shape and drive the medical writing strategy across therapeutic areas within Clinical Development. You will partner with senior clinical leaders to produce high-quality, strategically aligned deliverables supporting regulatory requirements and publications, while guiding messaging and program plans.

You will lead global teams, manage budgets and timelines, and mentor staff to ensure lifecycle management and successful regulatory

Qualifications

• Minimum 8 years medical writing experience in biopharma or CRO.
• At least 3 years in a supervisory role.
• Strong understanding of clinical development and regulatory submission processes.
• Experience with CTD submissions and regulatory guidelines.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Leads medical writing contributions to assigned therapeutic areas.
• Partners with Global Leaders to align development strategy with medical writing needs.
• Oversees budget, timelines, forecasting and resource allocation for medical writing.
• Mentors and manages senior medical writers and medical writers.
• Ensures accuracy and consistency of messages across regulatory documents and publications.
• Builds best practices, SOPs and content guides for efficient deliverables.

Skills

Medical writing

Regulatory submissions

Leadership

Cross-functional collaboration

eCTD

MS Office

Education

PhD or MD preferred

Tools

MS Office

Job description

IQVIA is seeking an Associate Director of Medical Writing to shape and drive the medical writing strategy across therapeutic areas within Clinical Development. You will partner with senior clinical leaders to produce high-quality, strategically aligned deliverables supporting regulatory requirements and publications, while guiding messaging and program plans.

You will lead global teams, manage budgets and timelines, and mentor staff to ensure lifecycle management and successful regulatory