Yoh has a contract opportunity for a Regulatory Document Specialist to join our client in Miami, FL.
- Review, track, and manage Clinical or Quality (CMC) study documentation for eCTD compliance and regulatory submission readiness.
- Scan, import, determine and capture metadata in Documentum according to standards.
- Ensure document integrity and submission readiness for submissions to health authorities.
- Make technical document corrections, format documents, and manage document styles.
- Create and manage electronic bookmarks, create inter-and-intra-document hyperlinks pre and post document publication.
- Identify and locate all related information in response to an internal or external customer inquiry.
- Other duties and responsibilities as assigned.
- High School Diploma or equivalent.
- Bachelor's Degree (Preferred).
- Years of experience preferred:
- A Minimum of one to two (1-2) years in a document management environment.
- Pharmaceutical / biotechnology experience (ICH, FDA, GMP).
- SOP: Standard Operation Procedure documentation experience.
Preferred Job Skills / Certifications / Knowledge:
- Analyzes documents and notes discrepancies.
- Demonstrates a working knowledge of Regulatory submission documents.
- Demonstrates familiarity with appropriate ICH, FDA, GMP guidelines and Company SOPs.
- Demonstrates a keen eye for detail.
- Demonstrates good organizational skills.
- Demonstrates good computer skills and an aptitude for software packages.
- Uses effective oral and written communication skills.
- Works effectively in a team environment and shares ideas, suggestions and comments with team members.
- Establishes and maintains cross-functional relationships.
Discover all that's possible with Yoh. Apply now.
- Familiarity with Microsoft Word.
- Adobe Acrobat.
- Electronic Document Systems.
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V .
Yoh Services, LLC
- 2 years ago - save job
Yoh Company is a unit of Yoh, one of the largest staffing services firms in the United States with more than 550 million USD in total...