Senior Medical Writer

Placements24; Polokwane; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision insurance

Retirement plan with employer matching

Generous paid time off

Professional development opportunities

Hybrid work model

Collaborative work environment

Job summary

Placements24 is seeking a Senior Medical Writer in Polokwane, Limpopo, to join a leading pharmaceutical company. The role requires producing CSR, regulatory documents, and manuscripts while ensuring ICH compliance.

You will collaborate with clinical operations, regulatory, and R&D teams in a hybrid work setting. The ideal candidate has 5+ years of medical writing experience in pharma/biotech, strong writing/editing skills, and proficiency in Word and document management systems.

Qualifications

• Minimum 5 years of medical writing experience in pharma/biotech.
• Strong knowledge of ICH guidelines and regulatory submission processes.
• Excellent writing, editing and proofreading skills.
• Ability to manage multiple projects in a hybrid environment.
• Proficiency in Word and document management systems.

Responsibilities

• Author and edit CSR, protocols, IBs, and regulatory documents.
• Prepare INDs, NDAs, and responses to health authority queries.
• Develop manuscripts and abstracts for journals and meetings.
• Coordinate reviews with clinicians, statisticians, and regulatory experts.
• Mentor junior medical writers and maintain templates.

Skills

Scientific writing

Editing

Cross-functional collaboration

Communication

Education

Bachelor's or Master's in life sciences/pharmacy

PhD advantageous

Tools

Microsoft Word

Document management systems

Job description

About the Role

Our client, a leading pharmaceutical company dedicated to advancing global health, is seeking a highly skilled Senior Medical Writer to join their dynamic team. This role will be based in **Polokwane, Limpopo**, and will operate under a flexible hybrid work model, allowing for a balance between in-office collaboration and remote work. The Senior Medical Writer will be responsible for the creation, editing, and management of a wide range of regulatory and scientific documents. This includes clinical study reports, regulatory submission documents, manuscripts, and abstracts, ensuring clarity, accuracy, and compliance with all relevant guidelines. You will collaborate closely with cross-functional teams, including clinical operations, regulatory affairs, and R&D, to translate complex scientific data into compelling and understandable communications. This is an excellent opportunity to contribute significantly to drug development and regulatory processes from Polokwane.

Key Responsibilities

• Author, edit, and manage the production of high-quality clinical study reports (CSRs), protocols, Investigator Brochures (IBs), and other clinical trial documents.
• Prepare and finalize various regulatory submission documents, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and responses to health authority queries.
• Develop manuscripts for publication in peer-reviewed journals and prepare abstracts and presentations for scientific meetings.
• Ensure all documents are scientifically accurate, grammatically correct, and adhere to relevant style guides and regulatory requirements (e.g., ICH guidelines).
• Collaborate effectively with subject matter experts, including clinicians, statisticians, and regulatory specialists, to gather necessary information and ensure scientific integrity.
• Manage document review processes, coordinating input from multiple stakeholders and resolving discrepancies.
• Stay current with evolving regulatory requirements and industry best practices in medical writing.
• Mentor and provide guidance to junior medical writers.
• Contribute to the development and maintenance of departmental templates and style guides.
• Ensure timely completion of all writing projects according to established timelines.

Requirements

• Bachelor's or Master's degree in a life science, pharmacy, or related field. A Ph.D. is an advantage.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven expertise in writing various types of regulatory and clinical documents.
• In-depth understanding of ICH guidelines, regulatory submission processes, and drug development lifecycle.
• Exceptional writing, editing, and proofreading skills with meticulous attention to detail.
• Strong analytical and critical thinking abilities.
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team.
• Proficiency in Microsoft Office Suite, particularly Word. Experience with document management systems is a plus.
• Ability to manage multiple projects simultaneously and meet tight deadlines in a hybrid work environment.

Benefits

• Competitive salary and potential for annual bonuses.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan with employer matching.
• Generous paid time off and holidays.
• Opportunities for professional development and attending scientific conferences.
• Hybrid work model offering flexibility and convenience.
• Collaborative and stimulating work environment.