Clinical Trials Regulatory Specialist at Winship Cancer Institute managing regulatory affairs and supporting clinical trials research with a focus on regulatory compliance and communication.
About the role
- Specialist in Compliance, Training, & Documentation at Johnson & Johnson. Driving Quality and Compliance in customer service operations and supporting various projects within the organization.
Responsibilities
- Support and continually work within parameters established by a risk-based Quality Management System framework.
- Ensure readiness to deliver exemplary customer service in an efficient, quality driven manner while adhering to standard business procedures.
- Complete Departmental/Regional Change Control documentation and deliverables to ensure the on-time completion.
- Support internal and external audits to verify that regulatory and quality requirements have been met.
- Complete weekly, monthly and quarterly SOX controls within close week.
- Provide Quality & Compliance expertise on applicable projects.
- Lead and/or support key departmental/cross-functional projects, as assigned, by developing and applying in-depth knowledge of business processes and systems, as well as project management skills.
- Facilitate remediation of any audit findings.
- Use continuous improvement tools and methodology, including Process Excellence, LEAN, and project management, to identify, evaluate, challenge, develop solutions, and optimize business processes that drive measurable improvement.
- Regularly communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities.
- Conducts After Action Review (AAR) post-implementation and finds opportunities to continuously improve.
- Assist Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes, using technology and other platforms to standardize, leverage and/or eliminate manual interactions wherever possible.
- Support change management strategies by applying change management principles and tools.
- Serve as the Subject Matter Expert (SME) regarding documentation management, Quality and Compliance, and Job Function Curriculums (JFC).
Requirements
- Minimum of 0-2 years experience; 3-5 years of related experience preferred
- Understanding of Sarbanes-Oxley Act (SOX)
- Experience within a regulated, fast-paced business environment
- Ability to excel in ambiguous environment
- Proficiency in MS Office applications (Word, PowerPoint, Excel, Access, Outlook)
- Strong Collaboration, business partnering, influencing, and negotiating skills to develop and maintain effective business partnerships
- Proven process, problem-solving, analytical, organizational, and detail-oriented skills
- Experience in Quality, Compliance, Document Management/Control, Technical Writing, or Supply Chain position
- Master's degree preferred.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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