Regulatory Operations Documentation Specialist Manager (Contractor)

Qpex Biopharma, Inc • Florham Park, NJ

3d • $65 - $85

About The Position

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.
Detailed Description
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.

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.
• 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.

Nice To Haves

• Experience with ISI Toolbox or equivalent software packages.
• Experience in document management systems; Veeva is a plus.

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.

What This Job Offers

• Career Level: Manager