This position is responsible for overall quality control (QC) review and submission-ready publishing of nonclinical documents. The Senior Nonclinical Editor will copyedit, proofread, format, and perform internal consistency reviews of document content in accordance with company SOPs and processes to ensure documents meet required standards. This role supports all documents written by authors from Drug Metabolism and Biopharmaceutics (DMB), Chemistry Manufacturing and Controls (CMC), Toxicology (Tox), and Translational Sciences, and may assist with clinical document QC and publishing tasks when appropriate to meet submission timelines.
Summary of the Essential Functions of the Job
- Perform internal document QC review of nonclinical documents (e.g., DMB, CMC, TOX, TRS, PRECLIN) to ensure compliance with the Incyte Style Guide, template formatting, and submission‑ready standards.
- Copyedit and proofread for grammar, style, and formatting according to AMA and Incyte style guides.
- Ensure internal consistency and confirm that data are reported correctly, that statements accurately reflect a common message, and that text to tables, figures, and appendices is accurate and consistently presented.
- Check the reference list in documents, verify citation information via PubMed, order copies of references, and add them to the electronic document management system (EDMS), ensuring each reference is cross‑referenced in the document.
- Proofread documents against standard templates to ensure compliance with required sections and text.
- Perform publishing of PDF documents to Incyte submission‑ready standards, including compiling multiple PDF files to include appendices.
- Assist Medical Writing Operations staff with clinical document QC and publishing, as appropriate.
- Participate in process improvement initiatives and support Medical Writing staff with other tasks, as appropriate.
- Interact cross‑functionally to support clinical and nonclinical processes and template updates.
Minimum Requirements
- Bachelor’s degree in English, Basic Science, Business, or another analytical field with 4 years of related experience in the pharmaceutical industry, or 8+ years of experience in a discipline directly related to document production (e.g., medical writing, QC, editing, publishing).
- Strong working knowledge of editorial and publishing activities within Clinical Development.
- Proficient in Microsoft Word, including the ability to format tables, insert cross‑references, apply styles, and use templates. Experience with PowerPoint, Excel, Visio, Adobe.
- Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission‑ready standards.
- Experience with an EDMS (e.g., Veeva Vault or SharePoint).
- Ability to effectively communicate with vendors and manage outsourced editorial work.
- Keen attention to detail.
- Ability to manage multiple activities, prioritize effectively, and work in a fast‑paced, deadline‑driven environment.
- Strong organizational and time‑management skills.
- Strong verbal, written, and interpersonal communication skills.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion and are an equal‑opportunity employer.
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