Job Summary
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 review of document content in accordance with company SOPs and processes to ensure documents meet required standards. This role will support all documents written by authors from Drug Metabolism and Biopharmaceutics (DMB), Chemistry Manufacturing and Controls (CMC), Toxicology (Tox), and Translational Sciences. This position may also assist in clinical document QC and publishing tasks when appropriate to meet submission timelines. The Senior Nonclinical Editor performs the activities with minimal oversight needed.
Summary of the Essential Functions of the Job
- Perform internal document QC review of nonclinical documents (eg, DMB, CMC, TOX, TRS, PRECLIN) to ensure compliance with the Style Guide, template formatting, and submission ready standards.
- Copyedit/proofread for grammar, style, and formatting according to AMA and style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect a common message and text to tables, figures, and appendices are accurate and consistently presented.
- Check the reference list in documents, including verifying citation information via 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.
- Perform publishing of PDF documents to submission-ready standards. May involve multiple document compilation of 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.
- May interact cross-functionally to support clinical and nonclinical processes and template updates.
Minimum Requirements
- Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 8+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).
- Strong working knowledge of the 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 in the use of an EDMS (eg, 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
