Senior Document Review Specialist

hace 5 días

Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo
About the Role

We 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 Responsibilities
  1. Document Review: Review highly technical documents, including regulatory submissions, integrated clinical study reports, and serious adverse event narratives, to ensure they meet or exceed client expectations.
  2. Data Integrity: Verify data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
  3. Editing and Revisions: Edit documents for accuracy, consistency, and grammatical correctness, and revise scientific language for usage, flow, clarity, and audience appropriateness.
  4. Team Collaboration: Coordinate the work of team members, track the status of documents being reviewed, and mentor junior team members.
  5. Client Communication: Represent the department at meetings with clients and contribute to the development and modification of the quality review process.
Requirements
  1. Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  2. Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  3. Skills: Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (ICH), and requirements of the FDA and other international regulatory agencies.
  4. Communication: Effective oral and written communication skills, with the ability to work on own initiative and collaborate with a team in a cross-cultural, geographically dispersed environment.
About Thermo Fisher Scientific

We are a leading provider of scientific instrumentation, software, and services that enable our customers to make the world healthier, cleaner, and safer. Our company culture is built on the values of integrity, intensity, innovation, and involvement, and we are committed to accelerating research, solving complex scientific challenges, and supporting patients in need.

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