Sponsor Dedicated Senior Medical Editor (QC of Clinical Documents)
Home-Based Opportunities in EU
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Overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
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Clinical Development Model
Our model brings the customer and patient to the center of everything we do.
We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
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Job Responsibilities
* Perform quality control review of clinical documents intended for submission to health authorities worldwide.
* Copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes.
* Oversee the workload for editors, establishing schedules and interacting with cross-functional authors.
* Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks as appropriate.
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Qualifications
* Bachelor's degree in English, Basic Science, Business, or other analytical field with solid experience in the pharmaceutical industry in medical writing, QC, editing, publishing of all clinical documents.
* Strong working knowledge of the editorial and publishing activities within Clinical Development.
* Experience as Medical Editor in a Pharmaceutical company/CRO environment required.
* Document QC experience including clinical protocols, clinical study reports, investigator's brochures, CTD summary modules.
* Submission publishing task experience including creating bookmarks and hyperlinks within a single PDF document as well as external hyperlinks to multiple PDF documents.
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Key Skills
* Proficient in Microsoft Word including formatting tables, inserting cross-references, applying styles, and using 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 such as Veeva Vault or SharePoint.
* Ability to effectively communicate with vendors and manage outsourced editorial work.
* Keen attention to detail.