Regulatory Document Review Expert
hace 2 meses
We are seeking a highly skilled and detail-oriented Senior Document Review Specialist to join our team at Thermo Fisher Scientific. As a key member of our FSP Medical Writing team, you will be responsible for reviewing and ensuring the quality of documents to meet or exceed client expectations.
Key Responsibilities- Review highly technical documents of all types to ensure a quality standard that meets or exceeds client expectations.
- Ensure 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.
- 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.
- Coordinates the work of team members and tracks the status of documents being reviewed.
- Mentors junior team members.
- May represent the department at meetings with clients.
- Contributes to the development and modification of the quality review process.
- Collaborates with the writer to manager alliance account(s).
- 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 5+ years).
- Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message.
- Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines ( ICH), and requirements of the FDA and other international regulatory agencies.
- Familiarity with interpreting data and excellent analytical ability.
- Effective oral and written communication skills.
- Good organizational and planning skills.
- Good interpersonal skills.
- Ability to work on own initiative.
- Good computer literacy and expertise.
- Competent word processing skills.
- Solid understanding of document management systems.
- Suitable level of expertise within a broad range of medical writing projects.
- Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures.
- Capable of providing general advice and training to others.
- 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.
Thermo Fisher Scientific is a leading provider of scientific instrumentation, software, and services. We are committed to enabling our customers to make the world healthier, cleaner and safer. Our team of 100,000+ colleagues share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
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