Document Management Specialist

🔥 25 minutes ago

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Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

💰 Private equity on 2021-05

Pharmaceuticals • Biotechnology • B2B

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Ensure compliance with relevant guidelines and regulations in a GxP environment • Responsible for Document Management in the eDMS MasterControl • Collaborate with line manager and QA team

🎯 Requirements

• Bachelor’s Degree in a science or related field required • 2-3 or more years of relevant industry experience in Document Control in Quality Assurance • 2 or more years of experience in Document Control in MasterControl • Working experience in quality system programs • Excellent written and oral communication skills • Proficient in Microsoft Word, Excel and PowerPoint • Strong multitasking and organization skills with a high level of attention • Demonstrated ability to work in a cross-functional team • Well-honed ability to work independently, think critically, take initiative and set priorities • Ability to meet strict deadlines, flex with changing priorities • Health Authority and/or Notified Body experience a plus

🏖️ Benefits

• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams • Equal Opportunity Employer • Reasonable Accommodations