Document Management Specialist

Job Description

· Support Trial Master File (TMF) set-up, maintenance, update, archival and

closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations.

· Reviews, edits, formats master documents according to approved procedures and

templates, maintains document properties (metadata), monitors document status

and approval notifications, distributions, and archiving.

· Conduct detailed and appropriate quality checks (QC) on TMF documents at

defined time points, including any paper originals required.

· Ensure that privacy and security standards are met and adhered to. Ensure that

documents are maintained in accordance with retention practices.

· Assist in routine internal and external master file audits to ensure compliance with

applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines.

Qualifications

· Bachelor’s degree required. Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.

· Minimum 3 years of experience in Document Control, Quality Assurance or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environment for Document Management Specialist role; >5 years required for Sr. Document Management Specialist role.

· Proficiency in working with Electronic Document Management Systems; Veeva Vault experience is a plus

· Exhibits a good understanding of general quality assurance concepts and practices

· Highly organized with a strong attention to detail

· Proficiency in web-based systems and project management applications (eg. Microsoft Office, SharePoint, etc.)

Additional Information

· Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders

Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.