Senior Medical Writer - Clinical Study Reports

Placements24; Paarl; Vor Ort; ZAR 950.000 - 1.500.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Health insurance

Retirement plan

Paid time off

Professional development

Collaborative work environment

Exposure to diverse therapeutic areas

Zusammenfassung

Placements24 is seeking a Senior Medical Writer for an office-based role in Paarl, Western Cape. You will author CSRs and regulatory documents, ensuring alignment with ICH guidelines and global regulatory standards, while collaborating with clinical development teams and regulatory affairs.

The position requires a minimum of 5 years in pharma/biotech medical writing with strong CSR focus, and an ability to translate complex data into clear language for diverse audiences.

Qualifikationen

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Chemistry, Biology).
• Master’s or Ph.D. is highly preferred.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a strong focus on authoring CSRs.
• In-depth understanding of clinical trial processes, study designs, and regulatory requirements for drug development.
• Proven ability to interpret and present complex clinical and statistical data effectively.
• Exceptional written and verbal communication skills, with impeccable grammar and attention to detail.
• Proficiency in using document management systems and authoring tools.
• Strong organizational and time management skills, with the ability to manage multiple projects and meet tight deadlines.
• Ability to work collaboratively within a team environment and build effective working relationships with diverse stakeholders.
• Familiarity with ICH guidelines and global regulatory submission requirements.
• Experience in specific therapeutic areas is an asset.

Aufgaben

• Author clear, accurate, and scientifically rigorous clinical study reports (CSRs) for Phase I-IV clinical trials.
• Develop other key regulatory documents, including investigator brochures, study protocols, safety narratives, and manuscript summaries.
• Ensure all documents are prepared in accordance with company style guides, ICH guidelines, and relevant regulatory agency requirements (e.g., FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, data management, and regulatory affairs, to gather information and ensure scientific accuracy.
• Review and edit documents authored by other writers or team members, providing constructive feedback.
• Manage document timelines and project priorities to meet submission deadlines.
• Maintain up-to-date knowledge of regulatory guidelines and industry best practices in medical writing.
• Participate in the development and implementation of medical writing standards and processes.
• Translate complex scientific and statistical data into clear, concise, and understandable language for various audiences.
• Ensure consistency of information across multiple documents and submissions.

Kenntnisse

Medical writing

CSR authoring

Regulatory knowledge

ICH guidelines

Attention to detail

Communication skills

Document management

Time management

Ausbildung

Bachelor’s in Life Sciences/Pharmacy/Chemistry/Biology

Master’s or PhD

Jobbeschreibung

About the Role

Our client, a leading global pharmaceutical company with a strong commitment to transparency and regulatory excellence, is seeking a highly skilled Senior Medical Writer. This critical role focuses on authoring comprehensive clinical study reports (CSRs) and other essential regulatory documents that underpin drug development submissions. This is an office-based position located in Paarl, Western Cape , requiring close collaboration with clinical development teams, biostatisticians, and regulatory affairs specialists. The Senior Medical Writer will ensure that scientific and medical information is presented accurately, clearly, and in compliance with global regulatory standards. This is an exceptional opportunity to contribute to the success of life-changing medicines by producing high-quality, scientifically sound documentation.

Key Responsibilities

• Author clear, accurate, and scientifically rigorous clinical study reports (CSRs) for Phase I-IV clinical trials.
• Develop other key regulatory documents, including investigator brochures, study protocols, safety narratives, and manuscript summaries.
• Ensure all documents are prepared in accordance with company style guides, ICH guidelines, and relevant regulatory agency requirements (e.g., FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, data management, and regulatory affairs, to gather information and ensure scientific accuracy.
• Review and edit documents authored by other writers or team members, providing constructive feedback.
• Manage document timelines and project priorities to meet submission deadlines.
• Maintain up-to-date knowledge of regulatory guidelines and industry best practices in medical writing.
• Participate in the development and implementation of medical writing standards and processes.
• Translate complex scientific and statistical data into clear, concise, and understandable language for various audiences.
• Ensure consistency of information across multiple documents and submissions.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Chemistry, Biology).
• A Master's or Ph.D. is highly preferred.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a strong focus on authoring CSRs.
• In-depth understanding of clinical trial processes, study designs, and regulatory requirements for drug development.
• Proven ability to interpret and present complex clinical and statistical data effectively.
• Exceptional written and verbal communication skills, with impeccable grammar and attention to detail.
• Proficiency in using document management systems and authoring tools.
• Strong organizational and time management skills, with the ability to manage multiple projects and meet tight deadlines.
• Ability to work collaboratively within a team environment and build effective working relationships with diverse stakeholders.
• Familiarity with ICH guidelines and global regulatory submission requirements.
• Experience in specific therapeutic areas is an asset.

Benefits

• Competitive salary and annual bonus.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Generous paid time off and company holidays.
• Opportunities for professional development and continuing education.
• A professional and collaborative work environment within a reputable pharmaceutical company.
• Exposure to diverse therapeutic areas and innovative drug development programs.