Senior Medical Writer - Clinical Study Reports

Placements24; Polokwane; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Health/dental/vision insurance

Retirement plan with company match

Paid time off

Home office stipend

Professional growth opportunities

Flexible remote work

International team environment

Job summary

Placements24 is seeking a Senior Medical Writer to join a fully remote team. The role involves authoring CSRs, protocols, and regulatory documents for a portfolio of pharmaceutical products, with collaboration across clinical operations, biostatistics, and regulatory affairs.

The ideal candidate has 5+ years in medical writing, deep knowledge of ICH-GCP, and exceptional writing and editing skills. This position offers remote flexibility, international collaboration, and opportunities to

Qualifications

• Bachelor's or Master's degree in a life science, medical, or related field.
• Minimum of 5 years of experience as a Medical Writer in pharma/biotech.
• Proven expertise in authoring clinical study reports (CSRs).
• Strong knowledge of ICH-GCP and regulatory submission requirements.
• Excellent writing, editing, and proofreading skills.
• Ability to interpret complex data and work remotely.

Responsibilities

• Author and edit clinical study reports (CSRs) according to ICH guidelines and company standards.
• Develop clinical trial protocols, investigator brochures, and other essential regulatory documents.
• Ensure scientific accuracy, clarity, and consistency in all written documentation.
• Collaborate effectively with clinical operations, biostatistics, regulatory affairs, and project management teams.
• Manage multiple writing projects simultaneously, adhering to strict deadlines.
• Review and revise documents based on internal and external feedback.
• Stay current with relevant guidelines (ICH, FDA, EMA) and therapeutic areas.
• Contribute to the development of style guides and templates for medical writing.
• Mentor and guide junior medical writers as needed.

Skills

Medical writing

Regulatory writing

CSR writing

Editing

Remote collaboration

Education

Bachelor's/Master's in life sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

About the Role

Our client is seeking an experienced Senior Medical Writer to join their expanding team, operating under a fully remote work model. This role is crucial for the clear, concise, and accurate communication of clinical trial data. You will be responsible for authoring high-quality clinical study reports (CSRs), protocols, and other regulatory documents for a diverse portfolio of pharmaceutical products. This position offers the opportunity to work with leading experts in the field and contribute to regulatory submissions that can impact global health. The ideal candidate possesses exceptional writing skills, a deep understanding of clinical research methodology, and the ability to translate complex scientific information into accessible narratives. As a fully remote employee, you will benefit from flexibility while maintaining high standards of quality and collaboration within a virtual setting. Your contributions will be vital in presenting clinical research findings effectively to regulatory bodies and stakeholders.

Key Responsibilities

• Author and edit clinical study reports (CSRs) according to ICH guidelines and company standards.
• Develop clinical trial protocols, investigator brochures, and other essential regulatory documents.
• Ensure scientific accuracy, clarity, and consistency in all written documentation.
• Collaborate effectively with clinical operations, biostatistics, regulatory affairs, and project management teams.
• Manage multiple writing projects simultaneously, adhering to strict deadlines.
• Review and revise documents based on internal and external feedback.
• Stay current with relevant guidelines (e.g., ICH, FDA, EMA) and therapeutic areas.
• Contribute to the development of style guides and templates for medical writing.
• Mentor and guide junior medical writers as needed.

Requirements

• Bachelor's or Master's degree in a life science, medical, or related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven expertise in authoring clinical study reports (CSRs).
• Thorough understanding of clinical trial processes, ICH-GCP, and regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills.
• Strong analytical and critical thinking abilities.
• Ability to interpret complex statistical data and scientific information.
• Excellent communication and interpersonal skills for effective collaboration in a remote environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Benefits

• Competitive salary package.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Generous paid time off and holidays.
• Home office stipend and technology support.
• Opportunities for professional growth and skill development.
• Flexible remote work arrangement.
• Work with a collaborative and supportive international team.