Clinical Editor
vor 1 Woche
**Job Summary**
This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards. This position reports to the Manager of Medical Writing Operations.
**Summary of the Essential Functions of the Job**
- Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and select Module 2 clinical summary documents) to ensure compliance with the Incyte Style Guide and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and Incyte style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
- Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Assist with publishing of nonclinical and clinical documents and the compilation of required CSR appendices.
- Participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
**Minimum Requirements**
- Bachelor’s degree in English, Basic Science, Business, or other analytical field with 2 years related experience in the pharmaceutical industry OR 5+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing).
- Experience in the use of an EDMS (eg, Veeva, or Documentum-based system).
- Keen attention to detail.
- Ability to manage multiple activities, prioritize effectively, and work in a fast-paced, deadline-driven environment.
- Strong verbal, written, and interpersonal communication skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).