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New, Posted 5 hours ago

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Document Review Specialist II/Senior Document Review Specialist (FSP)

Thermo Fisher Scientific

Olney, MD

OnsiteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

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)
Knowledge, Skills and Abilities: Capable of focusing on document details and the overall objectives and intent of document messaging
Knowledge, Skills and Abilities: Good knowledge of the methods, techniques, and procedures of medical writing tasks
Knowledge, Skills and Abilities: Strong analytical ability
Knowledge, Skills and Abilities: Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies
Knowledge, Skills and Abilities: Attentive to detail and quality of documents, thorough and methodical
Knowledge, Skills and Abilities: Proficient oral and written communication and grammatical skills
Knowledge, Skills and Abilities: Good organizational and planning skills
Knowledge, Skills and Abilities: Good interpersonal skills
Knowledge, Skills and Abilities: Proven ability to work effectively in a team environment
Knowledge, Skills and Abilities: Advanced computer literacy and expertise
Knowledge, Skills and Abilities: Good knowledge and understanding of document management systems
Knowledge, Skills and Abilities: Capable of working well under pressure and remaining motivated
Knowledge, Skills and Abilities: Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment