The World Leader In Serving Science
Document Review Specialist II – Senior Document Review Specialist
Location
Maryland
Posted
2 days ago
Salary
$85K - $100K / year
Seniority
Senior
Job Description
Document Review Specialist II – Senior Document Review Specialist
Thermo Fisher Scientific
• 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
Job 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
- 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
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