Sponsor Dedicated Senior Medical Editor (Qc Of Clinical Documents) - Home Based Several Locatio[...] Milano

Sponsor Dedicated Senior Medical Editor (Qc Of Clinical Documents) - Home Based Several Locatio[...]
Milano
Lombardia, Milano

Sponsor Dedicated Senior Medical Editor (QC of clinical documents) - Home Based Several Locations in EUUpdated: December 23, 2024

Location: Italy-Europe - ITA-Home-Based

Job ID:24006682

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Discover what our 29, 000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE Job Responsibilities 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.

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 Sponsor Style Guide and submission standards. Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards. Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA 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 What we're looking for 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 is required. Document QC experience (eg, clinical protocols, clinical study reports, investigator's brochures, CTD summary modules). The submission publishing task experience should be in creating bookmarks and hyperlinks within a single PDF document as well as external hyperlinks to multiple PDF documents. 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. At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.

If your past experience doesn't align perfectly, we encourage you to apply anyway.

At times, we take into consideration transferable skills from previous roles.

Syneos Health is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.

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