About the Role
Our client is seeking a skilled and experienced Medical Writer to contribute to their regulatory affairs and clinical development teams in East London . This role is instrumental in crafting clear, concise, and scientifically accurate documents essential for drug development, regulatory submissions, and clinical trial reporting. You will translate complex scientific and clinical data into high-quality documents that comply with global regulatory standards. This position offers a significant opportunity to work on diverse projects, collaborate with subject matter experts, and play a key role in bringing innovative medicines to patients, while enjoying a hybrid work arrangement that balances on-site collaboration with focused remote work.
Key Responsibilities
- Author, edit, and review a variety of regulatory documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submission modules (e.g., CTD).
- Ensure all documents are scientifically accurate, medically appropriate, and adhere to relevant guidelines (ICH, regulatory agency requirements).
- Collaborate effectively with cross-functional teams, including clinical investigators, statisticians, regulatory affairs specialists, and project managers.
- Manage document development timelines and ensure timely completion of assigned writing projects.
- Maintain a high level of knowledge regarding the therapeutic areas and products assigned.
- Contribute to the development and maintenance of style guides and templates for medical writing.
- Perform literature searches and synthesize information from various sources to support document creation.
Requirements
- Bachelor's or Master's degree in a life science, health science, or related field.
- Minimum of 3 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or medical device industry.
- Proven ability to write and edit complex scientific and clinical documents for regulatory purposes.
- In-depth understanding of clinical trial processes and regulatory submission requirements.
- Excellent written and verbal communication skills, with exceptional attention to detail.
- Proficiency in Microsoft Office Suite and familiarity with document management systems.
Benefits
- Competitive annual salary and potential for project-based bonuses.
- Comprehensive medical aid and retirement fund contributions.
- Generous annual leave and provision for professional development.
- Hybrid work model allowing for a flexible blend of office and remote work.
- Collaborative team environment with opportunities for professional growth in East London .
#J-18808-Ljbffr
Medical Writer - Regulatory Documents employer: Placements24
Our client offers an exceptional remote working environment for Tax Specialists, providing unparalleled flexibility and autonomy while ensuring a competitive salary package and performance bonuses. With a strong focus on continuous professional development, employees are encouraged to grow their expertise in South African tax law, all within a supportive culture that values strategic thinking and collaboration across departments.
