Senior Document Review Specialist
hace 7 días
We are seeking a highly skilled Senior Document Review Specialist to join our team at Mygwork, a leading platform for the LGBTQ+ business community. As a Senior Document Review Specialist, you will play a critical role in ensuring the quality and accuracy of documents related to clinical trials.
Key Responsibilities- Review highly technical documents 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 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.
- Maintain, communicate, and apply knowledge of current guidelines, templates, and industry standards.
- Coordinate the work of team members and track the status of documents being reviewed.
- Mentor junior team members.
- Represent the department at meetings with clients.
- Contribute to the development and modification of the quality review process.
- Collaborate with writers to manage alliance accounts.
- 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.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we 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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Senior Document Review Specialist
hace 1 semana
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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Senior Document Review Specialist
hace 2 semanas
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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Senior Document Review Specialist
hace 3 días
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAbout the RoleWe 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...
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Senior Document Review Specialist
hace 3 días
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAbout the RoleWe 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...
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Senior Document Review Specialist
hace 7 días
Barcelona, Barcelona, España Mygwork A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Document Review Specialist to join our team at Mygwork, a leading platform for the LGBTQ+ business community. As a Senior Document Review Specialist, you will play a critical role in ensuring the quality and accuracy of documents related to clinical trials, regulatory submissions, and medical writing...
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Senior Document Review Specialist
hace 7 días
Barcelona, Barcelona, España Mygwork A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Document Review Specialist to join our team at Mygwork, a leading platform for the LGBTQ+ business community. As a Senior Document Review Specialist, you will play a critical role in ensuring the quality and accuracy of documents related to clinical trials, regulatory submissions, and medical writing...
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Senior Document Review Specialist
hace 5 días
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAbout the RoleWe are seeking a highly skilled 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 documents to ensure quality and accuracy, with a focus on clinical trials.Key ResponsibilitiesDocument Review: Review highly technical documents,...
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Senior Document Review Specialist
hace 5 días
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAbout the RoleWe are seeking a highly skilled 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 documents to ensure quality and accuracy, with a focus on clinical trials.Key ResponsibilitiesDocument Review: Review highly technical documents,...
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Regulatory Document Review Expert
hace 1 semana
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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Regulatory Document Review Expert
hace 2 semanas
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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