Clinical Document Review Specialist

hace 1 mes

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

We are seeking a highly skilled and experienced 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 instructing others on the review process.

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).
Requirements
  • 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.
About Us

Thermo Fisher Scientific is a leading provider of scientific instrumentation, software, and services. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. 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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