Medical Writer - Clinical Documentation

Placements24; Soweto; Hybrid; ZAR 420.000 - 660.000; Vollzeit

Benefits dieser Stelle

Health insurance

Paid time off

Professional development

Collaborative team environment

Zusammenfassung

Placements24 is seeking a skilled Medical Writer to join its expanding team in Soweto, contributing to essential clinical documentation for pharmaceutical products. You will author, edit, and review regulatory and scientific documents to ensure clarity, accuracy, and compliance with global standards.

The role suits a detail-oriented writer with a strong scientific background who can translate complex data into accessible narratives for diverse audiences, supporting drug development and

Qualifikationen

• Bachelor’s degree in a scientific or medical field.
• Minimum 4 years of medical writing experience in pharma/biotech/medical device.
• Ability to write and edit complex regulatory documents clearly and concisely.
• Thorough knowledge of ICH guidelines and regulatory requirements.
• Proficiency in MS Office and document management systems.

Aufgaben

• Author, edit, and finalize CSR, protocols, IBs, and regulatory submissions.
• Ensure documents comply with regulatory guidelines and company style guides.
• Collaborate with clinicians, statisticians, and regulatory affairs to gather data.
• Review documents drafted by others or external vendors.
• Maintain understanding of therapeutic area and data for assigned projects.
• Manage document timelines and deliverables to meet project schedules.

Kenntnisse

Regulatory writing

Scientific writing

Editing

Communication

Project management

Ausbildung

Bachelor's degree in Life Sciences/Pharmacy/Nursing

Advanced degree preferred

Tools

MS Office

Document management systems

Jobbeschreibung

About the Role

Our client is seeking a skilled Medical Writer to join their expanding team, contributing to essential clinical documentation for pharmaceutical products in Soweto. You will be responsible for authoring, editing, and reviewing a variety of regulatory and scientific documents, ensuring clarity, accuracy, and compliance with global standards. This role is perfect for a detail-oriented writer with a strong scientific background who can translate complex data into comprehensible narratives for diverse audiences. Join a collaborative environment focused on delivering high-quality medical communications that support drug development and regulatory submissions.

Key Responsibilities

• Author, edit, and finalize clinical documents such as Clinical Study Reports (CSRs), protocols, investigator brochures (IBs), and regulatory submission documents.
• Ensure all documentation adheres to relevant regulatory guidelines (e.g., ICH, FDA, EMA) and company style guides.
• Collaborate closely with cross-functional teams, including clinicians, statisticians, and regulatory affairs specialists, to gather information and ensure document accuracy.
• Review and revise documents drafted by other team members or external vendors.
• Maintain a thorough understanding of the therapeutic area and the scientific data pertaining to assigned projects.
• Manage document timelines and deliverables efficiently, ensuring adherence to project schedules for initiatives impacting Soweto and beyond.

Requirements

• Bachelor's degree in a scientific or medical field (e.g., Pharmacy, Life Sciences, Nursing); advanced degree preferred.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated ability to write and edit complex scientific and regulatory documents clearly and concisely.
• Thorough knowledge of ICH guidelines and other relevant regulatory requirements for medical documentation.
• Proficiency in Microsoft Office Suite and experience with document management systems.
• Excellent communication, organizational, and project management skills.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance benefits.
• Paid time off and company-observed holidays.
• Opportunities for professional development and continuing education.
• A collaborative and supportive team atmosphere focused on scientific integrity and clear communication.