Senior Medical Writer - Clinical Study Reports

Placements24; Randburg; Hybrid; ZAR 700,000 - 950,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive health benefits

Retirement savings plan

Professional development & career成长

Job summary

Placements24 is seeking a Senior Medical Writer in Randburg for a hybrid role focused on CSRs and regulatory documents. You will collaborate with clinical development, regulatory affairs, biostatistics, and medical experts to report study outcomes with precision.

Ideal candidates hold a Master's or PhD in life/health sciences, 5+ years in pharma/biotech medical writing, and a strong grasp of ICH guidelines. The role emphasizes quality, timelines, and collaborative teamwork.

Qualifications

• Master's degree or Ph.D. in life science, health science or related discipline.
• Minimum of 5 years of experience as a medical writer in pharma/biotech.
• Strong understanding of ICH guidelines (E3) and drug development processes.
• Ability to translate complex clinical data into clear scientific text.
• Excellent written and verbal communication with high attention to detail.

Responsibilities

• Author, edit, and finalize CSRs per ICH guidelines and company standards.
• Develop IBs, protocols, amendments, manuscripts, and abstracts.
• Collaborate with investigators, study teams, biostatisticians and medical experts.
• Ensure consistency of terminology, style, and quality across documents.
• Manage multiple writing projects with strict timelines and milestones.
• Review data summaries, tables, and figures from biostatistics and CDM.
• Stay updated on regulatory guidelines and best practices.
• Contribute to medical writing templates and SOPs.
• Serve as a point of contact for medical writing inquiries from teams and stakeholders.
• Maintain high standards of clarity, accuracy, and scientific integrity.

Skills

Written & verbal communication

Attention to detail

Project management

Independent & collaborative work

Therapeutic area flexibility

Office/hybrid collaboration

Education

Master's degree or PhD in life/health sciences

Tools

Medical writing software

Job description

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.