Remote Clinical Editor working through an FSP model for a Global Oncology focused Pharmaceutical Company

The Clinical Editor is responsible for ensuring the quality of clinical documents intended for submission to health authorities worldwide. The Clinical Editor will review clinical documents for grammar, style, and formatting to ensure compliance with company standards and submission requirements. The responsibilities include but are not limited to the following:

• Performing quality control (QC) review of documents such as clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and select Module 2 clinical summary documents to ensure compliance with the sponsor company Style Guide and submission standards.
• Verifying data in documents against the source tables, figures, and listings and formatting tables according to Sponsor company standards.
• Copyediting and proofreading clinical documents for grammar, style, and formatting according to AMA and Sponsor company style guides.
• Checking the reference list in documents, including verifying citation information vs PubMed, ordering copies of references, adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
• Proofreading documents against the standard templates to ensure compliance with required sections and text.
• Participating in process improvement initiatives and assisting Medical Writing staff with other tasks, as appropriate.
• Overseeing the workload for the editors, establishing schedules, and interacting with cross-functional authors.
• Assisting with the training of more junior editors or contract staff.

Qualifications:

• Bachelor’s degree in English, Basic Science, Business, or another analytical field with 4 years 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).
• Strong working knowledge of the editorial 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, and Adobe preferred.
• Experience using an EDMS (e.g., Veeva, 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.