Principal Medical Writer

Responsibilities

• Act as Lead Medical Writer on diverse writing projects, advising on document types and performing senior reviews of all deliverables
• Manage customer relationships, including participating in bid defense meetings and negotiating timelines and comments
• Plan and organize workloads, track timelines, and implement customer requests for large medical writing programs
• Provide feedback, guidance, and training to staff to support departmental growth
• Lead global medical writing initiatives and represent the department in cross-functional Standard Operating Procedures (SOP) reviews
• Monitor and forecast budgeted hours and manage project finance activities

Requirements

• Bachelor's, Master's, or Ph.D. in life sciences or a related field
• At least 8 years of highly relevant medical writing experience
• Extensive experience independently preparing Clinical Study Reports (CSRs) and protocols to a high standard
• In-depth knowledge of drug development, medical writing, and associated regulatory requirements (including GCP)
• Strong understanding of statistical methods and the ability to interpret statistical analysis plans and outputs
• Excellent technical writing, grammatical, and oral communication skills
• Proven ability to manage multiple competing priorities and maintain effective working relationships at a senior level

Preferred Qualifications

• Experience preparing Common Technical Documents (CTDs)
• Experience tackling new or unusual document types and complex customer requirements

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.