Principal Medical Writier

## Principal Medical Writier Apply locations:
Durham, North Carolina, United States of America time type:
Full time posted on:
Posted Todayjob requisition :
R1548854
** 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 practicesIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create…