Medical Writer

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 company's 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