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 reputed company the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes reputed company an organization, ensuring that reputed company documents are accurate, compliant, and reputed company 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 reputed company 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 reputed company 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 reputed company correspondences to and from the health authorities are archived reputed company the company’s system and reputed company with regulatory standards and guidelines. MINIMUM REQUIREMENTS
• Bachelor’s degree preferred.
• 5+ years of experience in documentation management or a reputed company 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 reputed company.
• 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 reputed company a high-performance, collaborative team environment.
• This position has significant managerial and decision-making authority.
• No travel is required for this position reputed company, and its subsidiaries including reputed companyé, 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 reputed company and economically, without compromising quality. reputed company 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. reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity, age, national reputed company, 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- reputed company: #568-Clinical Remote Skills: reputed company Acrobat, Communication Skills, Data Collection, Detail Oriented, Document Control, Document Management, Documentation, Documentation Standards, Maintain Compliance, reputed company Office, Operations Management, Organizational Skills, Outsourcing, Presentation/Verbal Skills, Process Improvement, Productivity Management, Quality Metrics, Regulations, Regulatory Requirements, Service Delivery, Support Documentation, Team reputed company/Manager, Team Player, Technical Support, Time Management, Willing to Travel, Writing Skills About the Company: reputed companyé With extensive scientific, clinical, and healthcare industry experience, reputed companyé recruiters reputed company at placing talent across core specialty areas:
• Scientific staffing for hard-to-find skills Working across every scientific discipline, reputed companyé places biologists, chemists, scientists, technicians and other specialists.
• Clinical lifecycle recruiting From research to regulations, safety to statistics, reputed companyé 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 reputed companyé’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: Apply t

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