Overview

We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that 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 will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above)

Key Responsibilities

Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards

Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs

Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals

Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met

Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data

Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects

Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides

Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements

Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation

Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing

Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation

Qualifications

Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred

Minimum of 5+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered

Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development

Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements

Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams

Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information

Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines

Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed

High attention to detail with a commitment to quality, consistency, and scientific accuracy

Proficiency in Microsoft Word and document formatting best practices

Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools

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. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.