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Essential Functions
- Review highly technical documents of all types created within or outside of the company to ensure a quality standard that meets or exceeds client’s expectations.
- Verify scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
- Edit for accuracy, consistency, and grammatical correctness.
- Adjust schedule to accommodate unexpected requests for priority review.
- Revise scientific language for usage, flow, clarity, and audience appropriateness.
- Proactively query authors to ensure compatibility with unique preferences and scientifically sound judgment.
- Maintain, communicate, and apply knowledge of current guidelines, templates, and industry standards.
Qualifications
Education and Experience:
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- Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years). In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities
- Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document’s message.
- 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.
- Detail-oriented, thorough, and methodical.
- Proficient grammatical and communication skills, both oral and written.
- Good organizational and planning skills.
- Proven ability to work effectively in a team environment.
- Advanced computer literacy and expertise.
- Good 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.
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