Regulatory Operations Documentation Specialist Manager (Contractor)

Job Title: Regulatory Operations Documentation Specialist Manager (Contractor) Location: Remote (EST strongly preferred) Type: Contract Compensation: $65 - $85 hourly Contract: 12mns renewable

Overview

This role will lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an organization, ensuring that all documents are accurate, compliant, and efficiently managed. This role involves leading a team of documentation specialists, improving documentation workflows, and ensuring regulatory compliance. The scope of this role includes document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. It also includes the archiving of correspondences to and from the health authorities and internal and external GRM archiving. RESPONSIBILITIES

• Provide direction and support to the documentation team, ensuring high-quality work and adherence to standards.
• Train team on documentation standards, procedures, and tools to ensure consistency and compliance.
• Ensure all documents meet the organization's quality standards and regulatory requirements.
• Continuously enhance documentation processes to improve efficiency and productivity.
• Maintain document control processes for proper classification, indexing, distribution, and archiving.
• Ensure all documentation complies with industry regulations and standards.
• Work closely with other departments to gather information and ensure comprehensive documentation.
• Manage and Support team members that ensure all correspondences to and from the health authorities are archived within the company’s system and comply with regulatory standards and guidelines.

MINIMUM REQUIREMENTS

• Bachelor’s degree preferred.
• 5+ years of experience in documentation management or a related role
• 1+ years in a supervisory or leadership position
• Proven experience with document control systems and compliance standards
• Competencies
• Proficient in MS Office and Acrobat Adobe.
• Experience with ISI Toolbox or equivalent software packages.
• Experience in document management systems; Veeva is a plus.
• High level of attention to detail and accuracy in work.
• Effective time management and organizational skills.
• Strong written and verbal communication skills.
• Able to work within a high-performance, collaborative team environment.
• This position has significant managerial and decision-making authority.
• No travel is required for this position

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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. #M- #LI- #DI- Ref: #568-Clinical Remote Skills: Adobe Acrobat, Communication Skills, Data Collection, Detail Oriented, Document Control, Document Management, Documentation, Documentation Standards, Maintain Compliance, Microsoft Office, Operations Management, Organizational Skills, Outsourcing, Presentation/Verbal Skills, Process Improvement, Productivity Management, Quality Metrics, Regulations, Regulatory Requirements, Service Delivery, Support Documentation, Team Lead/Manager, Team Player, Technical Support, Time Management, Willing to Travel, Writing Skills About the Company: Joulé With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

• Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

• Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

• Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

• National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search. Company Size: 500 to 999 employees Industry: Biotechnology/Pharmaceuticals Founded: 0 Website: https://www.jouleinc.com/ Apply tot his job Apply To this Job