Senior Medical Writer - Clinical Study Reports in Southampton

About the Role

Our client, a dynamic global pharmaceutical company, is seeking a highly skilled Senior Medical Writer to join their expanding Medical Affairs team. This hybrid role offers the opportunity to contribute significantly to the documentation of clinical trial results and other scientific communications, with a focus on producing high-quality Clinical Study Reports (CSRs). Based in or near Randburg, Gauteng , you will work collaboratively with clinical development, regulatory affairs, and biostatistics teams to ensure accurate and timely reporting of study outcomes. The hybrid nature of this position allows for a blend of focused remote work and essential in-office collaboration, fostering both productivity and team synergy. Your expertise will be crucial in shaping the narrative of clinical research findings.

Key Responsibilities

• Author, edit, and finalize high-quality Clinical Study Reports (CSRs) in accordance with ICH guidelines, regulatory requirements, and company standards.
• Develop other key regulatory and clinical documents, such as Investigator's Brochures (IBs), protocols, amendments, manuscripts, and abstracts.
• Collaborate closely with clinical investigators, study teams, biostatisticians, and medical experts to gather necessary information and ensure scientific accuracy.
• Ensure consistency in terminology, style, and quality across all assigned documents.
• Manage multiple writing projects simultaneously, adhering to strict timelines and project milestones.
• Review and critically assess data summaries, tables, and figures provided by biostatistics and clinical data management.
• Stay updated on regulatory guidelines, industry best practices, and emerging trends in medical writing and scientific communication.
• Contribute to the development and refinement of medical writing templates and SOPs.
• Serve as a key point of contact for medical writing-related inquiries from internal teams and external stakeholders.
• Ensure all documentation adheres to the highest standards of clarity, accuracy, and scientific integrity.

Requirements

• Master's degree or Ph.D. in a life science, health science, or related discipline.
• Minimum of 5 years of experience as a medical writer in the pharmaceutical or biotechnology industry, with a strong focus on CSRs and regulatory documents.
• Comprehensive understanding of ICH guidelines (especially E3 for CSRs), GxP regulations, and the drug development process.
• Proven ability to interpret complex clinical data and translate it into clear, concise, and accurate scientific text.
• Excellent written and verbal communication skills, with exceptional attention to detail and grammatical precision.
• Strong organizational and project management skills, with the ability to manage multiple projects and deadlines effectively.
• Proficiency in medical writing software and tools, as well as standard office productivity suites.
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.
• Experience with various therapeutic areas is desirable.
• Must be able to commute to the office in Randburg, Gauteng for collaborative sessions as part of a hybrid work arrangement.

Benefits

Our client offers a competitive salary, comprehensive health benefits package, retirement savings plan, generous paid time off, and excellent opportunities for professional development and career growth. We promote a culture of scientific excellence and collaboration. This hybrid role provides flexibility while ensuring vital team interaction. Join our dedicated team in Randburg, Gauteng and make a significant impact on clinical reporting.

#J-18808-Ljbffr