Documentation Specialist

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with WEP Clinical processes, sponsor requirements, and applicable regulations • Collaborate with internal project teams to ensure timely retrieval, filing, and availability of essential documents • Maintain systems and tools used to evaluate, track, and transmit TMF documents • Conduct detailed quality checks and content reviews of eTMF documents, including required paper originals • Generate and provide TMF metrics and content reports to project management teams and leadership • Scan or coordinate scanning, label, upload, and appropriately file documents for traceability and accessibility • Ensure adherence to privacy, security, and document retention standards • Support TMF archival activities and long-term document storage strategies after project closeout • Assist with internal and external TMF audits for compliance with SOPs, policies, FDA, and ICH GCP guidelines • Maintain study status trackers and other project documentation tools • Label, sort, categorize, and retrieve documents • Assist with training staff on documentation practices • Perform proofreading and administrative tasks as needed

🎯 Requirements

• Bachelor’s degree preferred • 1–2 years of experience in order processing and documentation management systems preferred • Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices • Experience with clinical trial electronic databases preferred • Proven ability to meet quality and timeline objectives • Strong computer skills, including proficiency in Microsoft Office • Skilled in formatting and publishing documents, and maintaining tracking systems • Able to coordinate document review and finalization across multiple stakeholders • Quick to learn new software programs and databases • Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate • Candidates must reside in a U.S. state where the company is authorized to hire • This role is not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia • Resume must be submitted in English

🏖️ Benefits

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave • Wellness, growth and development, and team relationship initiatives • Team events • Inclusive, supportive work environment • Reasonable accommodations for qualified individuals with known disabilities • Smoke-free, drug-free, and alcohol-free work environment