Senior Medical Writer

About the role

IQVIA is seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. The role ensures documents such as Investigator's Brochures (IBs), Clinical Study Reports (CSRs) and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent and aligned with program objectives and global regulatory requirements. The successful candidate acts as lead writer for key summary documents, provides strategic guidance to cross-functional teams and oversees medical writing across multiple compounds. The position reports to the Director of Medical Writing (or above).

Key responsibilities

• Lead the development of clinical and regulatory documents (IBs, CSRs, clinical summaries, marketing authorization submissions) in line with ICH, FDA, EMA guidelines and internal standards.
• Serve as lead writer for key summary documents and oversee writing activities across multiple compounds or programs.
• Guide cross-functional teams on document content, messaging and regulatory positioning.
• Manage medical writing projects, including planning, timelines, resource coordination and delivery against milestones and deadlines.
• Work with Clinical, Regulatory Affairs, Biostatistics and Safety to gather, interpret and present clinical data.
• Mentor other medical writers and review and edit documents for accuracy, clarity and compliance with templates and style guides.
• Take part in project and team meetings and contribute to process improvement initiatives.
• Develop, maintain and refine SOPs, templates and best practices, and stay current with regulatory requirements and therapeutic area knowledge.

Required profile

• Bachelor's degree in a scientific, clinical, regulatory or related field; advanced degree (MSc, PhD, PharmD, MD) preferred.
• At least 5+ years of medical writing experience in biopharmaceutical, biotechnology or CRO settings; equivalent experience in clinical or preclinical development also considered.
• Knowledge of global regulatory requirements (ICH, FDA, EMA) across all phases of clinical development.
• Ability to lead writing for complex documents and work independently in a cross-functional team.

Required skills

• Microsoft Word and document formatting best practices.
• Electronic document management systems (eDMS) and familiarity with document templates, style guides and structured authoring tools.
• Strong written and verbal communication, organization, time management and project management skills.