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Documents Specialist II

1 hour, 31 minutes ago
India
Full-time
Senior
Technical Writer
Technical Writing and Documentation
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 109

Description

  • Prepare TMF plans for assigned studies.
  • Perform document quality control and indexing within the eTMF.
  • Monitor document submission timelines to prevent backlog and escalate issues to eTMF Management as needed.
  • Distribute TMF metrics and follow up on documents requiring clarification until resolved.
  • Manage study close-out activities, including final document submission timelines and wrap-up of document processing.
  • Request eTMF export, transfer records to the client, and obtain acknowledgement of receipt.
  • Maintain document activities in accordance with GCP, ICH E6, regulatory guidance, and Precision SOPs.

Requirements

  • 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum 5 years of clinical trial experience.
  • Minimum 3 years of experience with TMF and/or eTMF.
  • Established experience with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Ability to speak English proficiently at a professional level.
  • Working knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, or the ability to be trained and retain it.
  • Strong interpersonal skills and the ability to work independently and in a team environment.
  • Detail-oriented, self-motivated, and able to plan work independently.
  • Professional communication skills, both verbal and written.
  • Experience managing documents in a regulated clinical research environment (preferred).

Benefits

  • Equal Opportunity Employer status with nondiscriminatory hiring practices.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and California applicant privacy notice provided for applicant data handling.

Interested in this position?

Apply directly on the company website

Apply Now

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