Regulatory Operations Documentation Specialist, Manager
Shionogi Inc. (U.S.)
contract
Posted on:
Location Type: Remote
Location: New Jersey • United States
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Salary
💰 $65 - $85 per hour
About the role
- 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.
- Involve in improving documentation workflows, and ensuring regulatory compliance.
- Include document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities.
- Archive correspondences to and from the health authorities and internal and external GRM archiving.
- 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.
- 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.
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
- 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.
Benefits
- No travel is required for this position
- EEO Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
documentation managementdocument control systemsregulatory compliancequality controldocument formattingattention to detailtime managementorganizational skillssupervisory experiencedocument management systems
Soft Skills
leadershipcommunication skillscollaborationtrainingsupportefficiency improvementproblem-solvingteam managementdirectionconsistency