# Senior Medical Writer **Company**: IQVIA **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Centurion-South-Africa/Senior--Medical-Writer_R1560507-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_8b390ab1-9d8 ## Description 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. **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 ## Skills ### Required - medical writing - global regulatory requirements - clinical research processes - project management - communication skills - Microsoft Word - electronic document management systems ### Nice to have - advanced degree (e.g., MSc, PhD, PharmD, MD) - experience with eDMS and structured authoring tools --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Centurion-South-Africa/Senior--Medical-Writer_R1560507-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)