Regulatory Operations Documentation Specialist
Shionogi Inc. (U.S.) · Florham Park, NJ · 3 wk ago
RemoteRemoteLegal$40–$57/hrContract
Responsibilities
- Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
- Aid in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
- Affirmatively archive all communications with health authorities within the company’s system and ensure adherence to applicable regulatory guidelines.
- Assist in the archiving and retrieval of documents from offsite storage facilities.
- Provide ongoing support to the Regulatory Operations team.
Requirements
- High school degree required; Associate’s degree preferred.
- Pharmaceutical industry experience is a plus, but not required.
- Proficient in MS Office and Adobe Acrobat.
- Experience with ISI Toolbox or equivalent software packages.
- Experience with database 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.
Qualifications
None specified.
Skills
Microsoft Word, Adobe Acrobat, Veeva RIM.
Benefits
Not specified.
Pay
$40 - $57 per hour.
Schedule
Not specified.