at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Clinical Editor 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.
Essential Functions of the Job (Key responsibilities)
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.
May assist with publishing of nonclinical and clinical documents and the compilation of required CSR appendices.
May participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
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).
Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates. Experience with PowerPoint, Excel, Visio, Adobe preferred.
Experience in the use of an EDMS (eg, MasterControl 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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