Job Title: Clinical SOP WriterLocation: RemoteType: 12 month contractRequirements
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
Responsibilities
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.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.