Associate Medical Writer

Employer Industry: Biotechnology and Pharmaceutical Research

• Opportunity for career advancement and growth within the organization
• Supportive and collaborative work environment
• Chance to make a positive impact on patient safety and clinical documentation
• Work with a dynamic and dedicated team in a global company
• Engage in meaningful work that contributes to the development of new medicines

• Write, edit, and review clinical documentation, including informed consent forms and patient information
• Write, edit, review, finalize, and track clinical study report patient safety narratives
• Collect and track documents for clinical study report appendices, supporting Quality Control Associates
• Perform quality control reviews of developed documents in support of Quality Control Associates
• Act as a backup contact for Project Managers and other functional areas regarding assigned medical writing tasks

• College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences, or an equivalent combination of education, training, and experience
• Minimum 2 years of experience in medical and/or regulatory writing and related tasks
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior experience in pharmaceutical, biotechnology, or contract research organizations
• Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process

• Understanding of electronic Common Technical Document (eCTD) requirements
• Experience collaborating with process improvement teams in narrative automation

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