Research Associate (Contract)

Job Description

This position will work closely with Analytical, Process Development and Regulatory to manage data and documents. This position performs data review, manages critical document tracking, and will be a point of reference to ensure content in regulatory filings matches source documentation. Training will be provided to selected candidate.

This is a contract role.

Key Responsibilities:

• Contact subject matter experts and relevant parties to recover documents required for regulatory submissions and background source information
• Reconcile documents recovered against project plans / trackers to assure targets have been recovered
• Identify gaps where documents are not available
• Manage the movement of documents from Sharepoint to a Document Repository (QDoCCs and/or Veeva)
  
  
  
  • Create timelines with authors
  • Status follow up with reviewer's and approvers
  • Formatting documents
  
  
• Verify data in regulatory submissions matches data in source documents
• Create and manage datasets, including verifying the data against source documents
• Run metrics, scorecards and reports as necessary

Minimum Qualifications:

• High School Diploma, Associates Degree and/or Bachelors Degree or equivalent experience.

Skills:

• Attention to detail (Data QC)
• Ability to communicate clearly and directly when requesting documentation from owners (internal and external).
• Experience with creating/revising documents in an electronic document management system (QDoCCs preferred).
• Proficiency in creating tables in Word/Excel.
• MS Project, Excel, Word skills

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).