Senior Document Review Specialist
hace 3 días
We are seeking a highly skilled Senior Document Review Specialist to join our FSP Medical Writing team at Thermo Fisher Scientific. As a key member of our team, you will be responsible for reviewing documents to ensure quality and accuracy, ensuring integrity of data in tables against source documents, and mentoring junior team members.
Key Responsibilities- Review highly technical documents to ensure quality and accuracy, meeting or exceeding client expectations.
- Verify data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
- Edit documents 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 manage alliance account(s).
- Delegates weekly assignments to the quality review team and fields questions as appropriate.
- 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 (e.g. 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 innovative company that enables our customers to make the world healthier, cleaner, and safer. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Our company culture stands for integrity, intensity, involvement, and innovation, and we value diverse experiences, backgrounds, and perspectives. Join us in accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need.
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Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAbout the RoleWe 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 ResponsibilitiesReview highly technical...
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