Medical Writer - Clinical Study Reports

Placements24; The Islands (MS); Hybrid; USD 90,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Fully remote

Professional development support

Conference exposure

Job summary

Placements24 is seeking an experienced Medical Writer to join their fully remote global team, focusing on Clinical Study Reports (CSRs) for regulatory submissions. This role offers autonomy and collaboration with clinical operations, biostatistics, and regulatory affairs across multiple projects.

You will translate complex trial data into clear, compliant regulatory documents, maintaining high standards and contributing to template improvements across therapeutic areas.

Qualifications

• Bachelor’s or Master’s degree in life sciences or related field.
• Minimum of 5 years of experience as a Medical Writer with significant CSR focus.
• Expertise in ICH-E3 guidelines and regulatory documentation standards.
• Exceptional writing, editing, and proofreading with meticulous attention to detail.

Responsibilities

• Author, edit, and finalize CSRs and other regulatory documents (protocols, investigator brochures).
• Ensure documents comply with ICH/FDA/EMA guidelines and internal standards.
• Collaborate with biostatisticians and data managers to accurately interpret data.
• Manage document development timelines and coordinate reviews with stakeholders.
• Maintain understanding of therapeutic areas and study designs.
• Contribute to template development and writing process improvements.

Skills

Medical writing

CSRs

Editing

Attention to detail

Education

Bachelor's or Master’s in life sciences

Tools

Document management systems

Office software

Job description

About the Role

Our client is seeking a skilled and experienced Medical Writer specializing in Clinical Study Reports (CSRs) to join their fully remote global medical writing team, serving clients in the Paarl region and beyond. This role is critical for translating complex clinical trial data into clear, concise, and accurate regulatory documents. You will work closely with clinical operations, biostatistics, and regulatory affairs teams to produce high-quality documentation essential for drug development and regulatory submissions. This fully remote position offers significant autonomy and the opportunity to contribute to life-saving therapies from any location.

Key Responsibilities

• Author, edit, and finalize comprehensive Clinical Study Reports (CSRs) , protocols, investigator brochures, and other clinical regulatory documents.
• Ensure all documents are compliant with relevant guidelines (e.g., ICH, FDA, EMA) and company standards.
• Collaborate with biostatisticians and data managers to interpret clinical data and ensure its accurate representation in reports.
• Manage document development timelines and coordinate review processes with internal and external stakeholders.
• Maintain a strong understanding of therapeutic areas and study designs.
• Contribute to the development and refinement of document templates and writing processes.

Requirements

• Bachelor's or Master's degree in a life science, biomedical field, or related discipline.
• Minimum of 5 years of experience as a Medical Writer , with a significant focus on writing CSRs.
• Expertise in ICH-E3 guidelines for CSRs and other relevant regulatory documentation standards.
• Exceptional writing, editing, and proofreading skills with meticulous attention to detail.
• Ability to understand and clearly communicate complex scientific and statistical information.
• Proficiency with document management systems and standard office software.

Benefits

• Highly competitive annual salary and comprehensive benefits package.
• Fully remote work arrangement with flexibility in work hours.
• Professional development opportunities and support for attending industry conferences.
• Exposure to a wide range of pharmaceutical projects and therapeutic areas.
• Collaborative and supportive virtual team environment dedicated to scientific excellence.