Remote Medical Writer - Clinical Study Reports

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 360,000 - 600,000; Full time

Benefits offered by this job

Competitive salary

Fully remote

Health, dental & vision insurance

Professional development

Collaborative virtual team

Job summary

Placements24 is seeking a skilled Medical Writer to produce high-quality CSRs and regulatory documents in a fully remote setting. You will collaborate with clinical operations, biostatistics, and regulatory affairs to ensure accuracy and regulatory compliance, supporting submissions and written scientific communications.

The role requires a Life Sciences or related degree, at least 3 years of medical writing experience, and strong knowledge of ICH guidelines.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree is a plus.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven ability to write clear, concise, and scientifically accurate documents, especially CSRs.
• Thorough understanding of clinical trial processes, ICH guidelines, and regulatory submission requirements.
• Excellent written communication skills, strong attention to detail, and proficiency in medical terminology.

Responsibilities

• Author comprehensive Clinical Study Reports (CSRs) based on clinical trial data and statistical analysis.
• Prepare other regulatory documents, including Investigator's Brochures (IBs), protocols, and safety narratives.
• Ensure all medical writing outputs meet the required scientific standards, regulatory guidelines, and company SOPs.
• Collaborate with subject matter experts to ensure scientific accuracy and completeness of documentation.
• Manage multiple writing projects simultaneously, adhering to strict timelines and quality standards in a remote setting.

Skills

Medical writing

Regulatory writing

ICH guidelines

Attention to detail

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Job description

About the Role

Our client is seeking a skilled and detail-oriented Medical Writer to produce high-quality clinical study reports (CSRs) and other regulatory documents. This is a fully remote position, allowing you to contribute to critical pharmaceutical documentation from anywhere. You will work closely with clinical operations, biostatistics, and regulatory affairs teams to ensure the accuracy, clarity, and compliance of all written content. This role is essential for communicating clinical trial results effectively and supporting regulatory submissions, offering flexibility and autonomy.

Key Responsibilities

• Author comprehensive Clinical Study Reports (CSRs) based on clinical trial data and statistical analysis.


• Prepare other regulatory documents, including Investigator's Brochures (IBs), protocols, and safety narratives.


• Ensure all medical writing outputs meet the required scientific standards, regulatory guidelines, and company SOPs.


• Collaborate with subject matter experts to ensure scientific accuracy and completeness of documentation.


• Manage multiple writing projects simultaneously, adhering to strict timelines and quality standards in a remote setting.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree is a plus.


• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.


• Proven ability to write clear, concise, and scientifically accurate documents, especially CSRs .


• Thorough understanding of clinical trial processes, ICH guidelines, and regulatory submission requirements.


• Excellent written communication skills, strong attention to detail, and proficiency in medical terminology.

Benefits

• Competitive annual salary and performance incentives.


• Fully remote work opportunity with flexible hours.


• Comprehensive health, dental, and vision insurance coverage.


• Professional development and training opportunities to enhance writing skills.


• A collaborative and supportive virtual team environment, facilitating effective remote communication and project completion.