Clinical SOP Writer-III

Description:

The Clinical SOP Writer works 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 Client’s writing style guide and to standards for clinical procedures/documents. The Clinical SOP Writer may also perform QC review of clinical procedures.

Requirements:

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