Regulatory Operations Documentation Specialist Manager (Contractor)

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. 

• 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

Qualifications

• 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.

Other Requirements

• This position has significant managerial and decision-making authority.
• No travel is required for this position

Additional Information

The hourly rate for this position is $65-$85. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

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.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.