Overview
Remote
On Site
Hybrid
$37 - $39 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)
Skills
DOCUMENTATION
GCP
GLP
GXP
GMP
GDP
REGULATORY
TECHNICAL
READINESS
INSPECTION
Job Details
Payrate: $37.00 - $39.00/hr.
Summary:
The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.
Responsibilities:
Requirements:
Top Must Have Skill Sets:
Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22326
Summary:
The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.
Responsibilities:
- Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards.
- Track documentation milestones and follow up with contributors to ensure deadlines are met.
- Provide in-depth technical editing and proofreading support to maintain consistency with approved templates and formatting standards.
- Conduct rigorous QC checks to ensure all documents meet regulatory, procedural, and formatting requirements.
- Maintain and update controlled document templates and ensure consistent application across documents.
- Support audits and inspections through documentation readiness activities.
- Collaborate with cross-functional teams to execute document-related tasks and resolve workflow issues.
Requirements:
- Bachelor s degree and a minimum of 2 years of hands-on experience in document management, including workflow coordination and system administration.
- Proficiency with Viva or comparable document management platforms is required.
- Strong background in project management and technical writing is essential.
Top Must Have Skill Sets:
- Strong project management skills including milestone tracking and workflow oversight.
- High proficiency in technical editing and document formatting.
- Familiarity with regulatory documentation in a Google Cloud Platform or similar environment.
- Experience with document management systems and inspection readiness.
Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22326
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.