Sr. Nonclinical Editor

Primary Responsibilities

• Support all documents written by authors from Drug Metabolism and Biopharmaceutics (DMB), Chemistry Manufacturing and Controls (CMC), Toxicology (Tox), and Translational Sciences.
• May assist in clinical document QC and publishing tasks when appropriate to meet submission timelines.
• Perform internal document QC review of nonclinical documents (eg, DMB, CMC, TOX, TRS, PRECLIN) to ensure compliance with the our client’s Style Guide, template formatting, and submission ready standards.
• Copyedit/proofread for grammar, style, and formatting according to AMA and our client’s 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 our client’s submission-ready standards. May involve multiple document compilation of PDF files to include appendices.
• Aid 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.

Skills & 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.

Compensation

$120,000 to $150,000 per annum.