Principal Medical Writer

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

Overview

We are seeking an experienced Principal 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 Module II summaries that 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 7+ 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

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $84,400.00 - $211,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.