Medical Writer

Duration: 12+ Months

Job Summary:

• The Clinical SOP Writer edits and performs QC review of clinical procedures.
• The Writer may also eventually work with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures.
• The Writer ensures procedures and associated forms and templates are written to a high-quality standard and according to writing style guide and to standards for clinical procedures/documents.

Requirements:

• Bachelor’s degree in English or related subject, or Bachelor’s degree in science with proven writing experience
• Experience in pharmaceutical industry; knowledge of clinical development
• Proven writing, editing, and quality control review experience
• Proficiency in MS Word and Excel
• Considerable experience in applying writing style guidelines and standards
• A strong working knowledge of all clinical development functions and processes, compliance standards, and ICH, GCP, and regulatory requirements
• Customer-focused approach, with strong project management, multitasking, and interpersonal skills
• Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process
• Proven experience in developing, maintaining, and using electronic templates and working in an electronic document management system
• Excellent communication skills both oral and written at all levels

Education:

Bachelor’s degree

Shift:

Part time 1st shift