Senior Clinical Editor

Job Summary (Primary function) This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide.

The Senior 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, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.

The Senior Clinical Editor performs the activities with minimal oversight needed. 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 Module 2 clinical summary documents) to ensure compliance with the Style Guide and submission standards.
• Verify data in documents against the source tables, figures, and listings and format tables according to standards.
• Copyedit / proofread clinical documents for grammar, style, and formatting according to AMA and 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.
• Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
• Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
• May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
• Assist with training of more junior editors or contract staff.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• 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.