Regulatory Operations Documentation Specialist

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Provide support for document formatting and quality control in accordance with Shionogi standards for materials related to submissions.

• Assist in the remediation and quality control of PDF documents, including the creation of bookmarks and hyperlinks to ensure compliance with regulatory electronic file standards.

• Help ensure that all communications with health authorities are accurately archived within the company’s system and comply with relevant regulatory guidelines.

• Aid in the archiving and retrieval of documents from external storage facilities.

• Offer continuous support to the Regulatory Operations team.

⛳️ Requirements

• A high school diploma is required; an Associate’s degree is preferred.

• Experience in the pharmaceutical industry is advantageous, but not mandatory.

• Proficient in Microsoft Office and Adobe Acrobat.

• Familiarity with ISI Toolbox or similar software packages.

• Experience with database systems; knowledge of Veeva is a plus.

• A strong attention to detail and accuracy in tasks.

• Effective time management and organizational abilities.

• Excellent written and verbal communication skills.

• Capable of thriving in a high-performance, collaborative team setting.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and growth.

• A supportive and inclusive work environment.

• Competitive salary and performance-based incentives.