Principal Medical Writer

IQVIA

Lead Medical Writer at IQVIA producing regulatory documents for global submissions. Collaborating with cross-functional teams and overseeing medical writing activities across multiple programs.

Posted 6/4/2026full-timeCambridge • 🇬🇧 United KingdomLeadWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

medical writingclinical study reportsinvestigator’s brochuresregulatory submissionsdata analysisstudy designproject managementdocument reviewprocess improvementSOP development

Soft Skills

leadershipstrategic guidancecommunicationorganizational skillstime managementcollaborationattention to detailmentoringindependencequality commitment

Tools & Technologies

Microsoft Wordelectronic document management systemsdocument templatesstyle guidesstructured authoring tools

Certifications & Qualifications

Bachelor’s degreeMScPhDPharmDMD

Industry Keywords

biopharmaceuticalbiotechnologyCROglobal regulatory guidelinesICHFDAEMAclinical developmentpreclinical developmentclinical research processes

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Professional development opportunities