Regulatory Document Review Specialist II – Senior Document Review Specialist

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🔥 16 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $85k - $100k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations • Verifies scientific logic and clarity of the document by verifying data in tables, listings, and figures against source documents, checking for consistency according to current regulatory standards and guidelines • Edits for accuracy, consistency, and grammatical correctness • Adjusts schedule to accommodate unexpected requests for priority review • Revises scientific language for usage, flow, clarity, and audience appropriateness • Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment • Maintains, communicates, and applies knowledge of current guidelines, templates, and industry standards

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification required • 5 years of regulatory document review experience, including protocols, protocol amendments, clinical study reports, narratives, investigator brochures, regulatory responses, and submission modules (primarily Modules 2.5, 2.7.3, and 2.7.4) • Experience working in the pharmaceutical/CRO industry preferred • Experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred • Capable of focusing on document details and the overall objectives and intent of document messaging • Good knowledge of the methods, techniques, and procedures of medical writing tasks • Strong analytical ability • Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies • Attentive to detail and quality of documents , thorough and methodical • Proficient oral and written communication and grammatical skills • Good organizational and planning skills • Good interpersonal skills • Proven ability to work effectively in a team environment • Advanced computer literacy and expertise • Good knowledge and understanding of document management systems • Capable of working well under pressure and remaining motivated • Capable of working both independently and collaboratively with a team in a cross ‑ cultural, geographically dispersed environment

🏖️ Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount