Contract GCP SOP Writer

GCP SOP Writer Contractor (20-30 hours/week)
POSITION SUMMARY
The GCP SOP writer is responsible for drafting, editing and performing quality control review of Clinical Operations procedures.  The candidate will work with process owners, subject matter experts and relevant stakeholders to develop and revise Clinical Operations procedures.  The role involves creating and revising key documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs) and other applicable associated documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provides support with writing and editing SOPs and other applicable documents across the Clinical Development Operations organization
• Gathers information from internal stakeholders currently performing processes across the organization and recommends shared practices that consider the varied staff needs and provide consistency across the organization
• Ensures that SOPs are written in a user-friendly format and provide clear guidance to team members
• Develop new SOPs or revise current SOPs to ensure compliance with GCP guidelines, internal quality standards and inspection readiness activities
• Writes clear and concise SOPs that will guide staff team members in their day-to-day operations in accordance with current regulations
• Collaborates with cross-functional teams to identify process improvement opportunities and recommend changes to enhance efficiency and effectiveness
• Models our core values: Passion, Integrity, Innovation, and Patient Focus

REQUIREMENTS
Education

• BS/BA degree or equivalent required

Experience & Skills

• Minimum 8 years of experience biotechnology/pharmaceutical company. Experience with SOP writing for a start-up company a plus
• At least 5 years’ prior experience in developing and editing GxP Standard Operating Procedures including a minimum of 3 years’ in developing Clinical SOPs
• Must have an understanding of GCP guidelines, regulatory requirements (e.g. FDA, EMA)
• Effective organizational skills and a high regard for attention to detail
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Candidate can be local or remote
• Excellent writing, editing, and communication skills. Strong attention to detail and the ability to simplify complex processes
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Understanding of process documentation and standards
• A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology
• Self-motivated and able to motivate others
• Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
• Strong attention to detail and ability to prioritize tasks to meet critical deadlines
• Proficiency in Microsoft suite or products such as Word, Excel etc.