Senior Medical Writer & Regulatory Submissions Lead

IQVIA; Durham (NC); On-site; USD 84,000 - 211,000; Full time

Job summary

IQVIA is seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role will ensure documents such as Investigator’s Brochures, Clinical Study Reports, and Module II summaries are scientifically accurate and compliant with global guidelines.

The successful candidate will serve as the lead writer for key summary documents, guiding cross-functional teams while overseeing medical writing

Qualifications

• Bachelor’s degree in a scientific/clinical/regulatory field required.
• Advanced degree preferred (MSc/PhD/PharmD/MD).
• 7+ years of medical writing experience in biopharmaceuticals/ CROs.
• Strong knowledge of ICH FDA EMA regulatory guidelines.
• Ability to lead writing for complex documents and provide strategic input.
• Excellent communication and project management skills.

Responsibilities

• Lead development of high-quality clinical and regulatory documents in compliance with global guidelines and internal standards.
• Serve as the lead writer for key summary documents across multiple programs.
• Provide strategic guidance to cross-functional teams on document content and regulatory positioning.
• Manage medical writing projects including planning, timelines, resources, and milestones.
• Collaborate with Clinical, Regulatory, Biostatistics, Safety to accurately present data.
• Mentor and support other medical writers to ensure quality and consistency.
• Review and edit documents for accuracy, clarity, and templates compliance.
• Attend meetings to provide expert input on document development and data interpretation.
• Lead process improvement initiatives to enhance efficiency and quality in document prep.
• Develop SOPs, templates, and best practices for medical writing.
• Stay current with evolving regulatory requirements and industry trends.

Job description

IQVIA is seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role will ensure documents such as Investigator’s Brochures, Clinical Study Reports, and Module II summaries are scientifically accurate and compliant with global guidelines.

The successful candidate will serve as the lead writer for key summary documents, guiding cross-functional teams while overseeing medical writing