Quality Control, Medical Writer

The QC Medical Writer is responsible for performing Quality Control (QC) audits of medical writing deliverables that support the clinical oncology portfolio at Sumitomo Dainippon Pharma Oncology. The QC Medical Writer will assist in preparing simple to moderately complex clinical study documents (eg, clinical study protocols/amendments, sections of clinical study reports, safety narratives) as appropriate.

KEY RESPONSIBILITIES:

  • Provide quality control (QC) review of clinical regulatory documents.
  • Collaborate with other members of the Medical Writing team to ensure that all QC findings are addressed as appropriate.
  • Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
  • Assist in the development of templates and standard operating procedures (SOPs).
  • Assist in the production of high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function.
  • Other duties as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

  • Bachelor’s degree in a relevant scientific field is required.
  • A minimum of 2 years of document quality control experience in the biopharmaceutical industry with a working knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
  • Strong written and verbal communication skills, including fluency in oral and written English, with the ability to interpret data sufficiently to allow confirmation of associated text descriptions.
  • High attention to detail and an ability to retain focus over an extended period of time.
  • Experience with StartingPoint templates and AMA style.

Job Location: Remote

Equal Opportunity Employer

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