Regulatory Documentation Specialist Job
Yoh - Miami, FL

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Yoh has a contract opportunity for a Regulatory Document Specialist to join our client in Miami, FL.

Job Responsibilities:
  • 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.
Job Qualifications:
  • 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.
Skills:
  • Analysis:
  • Analyzes documents and notes discrepancies.
  • Technical:
  • 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.
  • Communication:
  • Uses effective oral and written communication skills.
  • Teamwork:
  • Works effectively in a team environment and shares ideas, suggestions and comments with team members.
  • Interpersonal:
  • Establishes and maintains cross-functional relationships.
Preferred Job Skills / Certifications / Knowledge:
  • Familiarity with Microsoft Word.
  • Adobe Acrobat.
  • Electronic Document Systems.
Discover all that's possible with Yoh. Apply now.

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 .

J2W: SCIENTIFIC

J2WSWSCI
Ref: 1013634
SFSF: LS

Yoh Services, LLC - 2 years ago - save job
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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...