Medical Writer - Pharmaceutical (Remote)

Placements24; Upington; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Performance-based bonus

Flexible hours

Remote work

Home office setup allowance

Professional development

Job summary

Placements24 is seeking a talented Medical Writer to join a global team. This fully remote role focuses on creating clear, accurate, and compliant scientific and regulatory documentation, including CSRs and regulatory submissions.

The ideal candidate holds a Life Sciences/Healthcare degree with 4+ years of medical writing experience in pharma/biotech and strong knowledge of ICH guidelines. Collaboration with cross-functional teams is essential in a remote setting.

Qualifications

• Bachelor's degree in a scientific or healthcare field.
• Master's or PhD is a plus.
• Minimum 4 years of medical writing experience in pharma/biotech.
• Experience with clinical study reports and regulatory documents.
• Strong knowledge of ICH guidelines and regulatory processes.

Responsibilities

• Author, edit, and review medical and regulatory documents such as CSRs and regulatory submissions.
• Ensure documents are accurate, clear, and compliant with guidelines.
• Collaborate with cross-functional teams to gather information.
• Manage multiple writing projects with tight timelines.
• Contribute to templates and style guides for consistency.
• Stay updated on regulatory requirements and best practices.

Skills

Medical writing

ICH guidelines

Regulatory submissions

Scientific communication

Detail-oriented

Remote collaboration

Education

Bachelor's degree in Life Sciences / Healthcare

Master's degree or PhD (preferred)

Job description

About the Role

Our client is seeking a talented and precise Medical Writer to join their global team, supporting critical communication needs within the pharmaceutical industry. This fully remote position focuses on creating clear, accurate, and compliant scientific and regulatory documentation. You will be responsible for authoring a variety of documents, including clinical study reports, regulatory submission documents, and scientific publications, ensuring they meet the highest standards of quality and regulatory adherence. This is an ideal opportunity for an experienced writer to contribute to significant pharmaceutical projects from a convenient remote location, playing a vital role in disseminating vital scientific information.

Key Responsibilities

• Author, edit, and review various medical and regulatory documents, including clinical study protocols, CSRs, investigator brochures, and regulatory submission documents.
• Ensure all documentation is scientifically accurate, clear, concise, and compliant with relevant guidelines (e.g., ICH, FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to gather information and ensure accuracy.
• Manage multiple writing projects simultaneously, adhering to strict timelines and project requirements.
• Contribute to the development of templates and style guides to ensure consistency in documentation.
• Stay updated on industry best practices and regulatory requirements for medical writing.

Requirements

• Bachelor's degree in a relevant scientific or healthcare field (e.g., Pharmacy, Life Sciences, Medicine).
• A Master's degree or Ph.D. is a plus.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven experience in authoring various types of clinical and regulatory documents.
• In-depth understanding of ICH guidelines, regulatory submission processes, and medical writing principles.
• Exceptional written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently, manage time effectively, and collaborate productively in a remote setting.

Benefits

• Competitive annual salary and performance-based bonuses.
• Flexible working hours and a fully remote work environment.
• Home office setup allowance.
• Opportunities for professional development and continued education.
• The chance to contribute to important pharmaceutical research and regulatory submissions.