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About Company

Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds client's expectations. Documents include regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols, and publications. Ensures the integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.

Position Name :

Document Review Specialist II

Organization :

Thermo Fisher Scientific

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc,

Experience:

4 Years

Salary:

14.6 Lakhs per year

Location:

Work From Home

Essential Functions

  • Review highly technical documents of all types created within or outside of the company to ensure a quality standard that meets or exceeds client’s expectations.
  • Verify 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.
  • Revise scientific language for usage, flow, clarity, and audience appropriateness.
  • Proactively query authors to ensure compatibility with unique preferences and scientifically sound judgment.
  • Maintain, communicate, and apply knowledge of current guidelines, templates, and industry standards.

Qualifications

Education and Experience:

  • 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 4+ years). In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities

  • Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document’s message.
  • Good knowledge of the methods, techniques, and procedures of medical writing tasks.
  • Strong analytical ability.
  • Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies.
  • Detail-oriented, thorough, and methodical.
  • Proficient grammatical and communication skills, both oral and written.
  • Good organizational and planning skills.
  • Proven ability to work effectively in a team environment.
  • Advanced computer literacy and expertise.
  • Good understanding of document management systems.
  • 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.

Application Link