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.

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 highquality work and adherence to standards.
• Train team on documentation standards procedures and tools to ensure consistency and compliance.
• Ensure all documents meet the organizations 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 companys system and comply with regulatory standards and guidelines.

Minimum Job Requirements

Qualifications

• Bachelors 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.
• Familiarity with regulatory compliance
• High level of attention to detail and accuracy in work.
• Effective time management and organizational skills.
• Strong written and verbal communication skills.
• Proficiency in training and mentoring document specialists
• Able to work within a highperformance collaborative team environment.

Other Requirements

• This position has significant managerial and decisionmaking authority.
• No travel is required for this position
• Must live a commutable distance to our US Corporate Headquarters in Florham Park NJ. Office presence required at least 50% of the time per month

To be considered for this position you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

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 nondiscriminatory.

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