Offer summary

Qualifications:

Minimum of 2 years of experience in TMF, Document Control, or Quality Assurance., Strong understanding of quality assurance and clinical trial concepts., Experience in the Biotechnology or Pharmaceutical industries., Familiarity with Veeva Vault is preferred..

Key responsibilities:

Support the set-up, maintenance, and archival of the Trial Master File (TMF).

Review, edit, and format master documents according to approved procedures.

Conduct quality checks on TMF documents and ensure compliance with regulations.

Assist in internal and external audits of the master file.

Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is seeking an experienced and knowledgeable TMF professional looking for an exciting new opportunity to join a growing business as a Document Management Specialist.

The Document Management Specialist position is responsible for processing study documentation in accordance with Standard Operating Procedures, Regulatory requirements, ICH and GCP guidelines and study specific TMF plans. This is a full remote position and can be performed within Serbia, Croatia and Bosnia.

Essential Functions:

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.

Necessary Skills and Abilities:

Exhibits a good understanding of general quality assurance & clinical trial concepts and practices.

A minimum of 2 years of experience in TMF, Document Control, Quality Assurance.
Experience in the Biotechnology, Pharmaceutical industries or a similar regulated environment

Experience working with Veeva Vault

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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

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