Senior Clinical QC Editor

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeting protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston’s top places to work for the past several years. For more information about our science, pipeline, and people, please visit www.kymeratx.com.

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll contribute:

• Review/edit clinical and regulatory documents for correct grammar, punctuation, syntax, and spelling
• Perform data integrity review of assigned documents to ensure scientific accuracy and minimally, adherence to the Kymera Style and Authoring Guide, the American Medical Association (AMA) Manual of Style, and/or the asset-specific conventions document
• Develop/prepare/use established MW internal checklists and best practices during editorial/QC review
• Establish and maintain QC assignment tracker and metrics
• Develop process improvement tools and develop or revise internal policies and/or SOPs affecting editorial/QC work
• Provide feedback to the lead medical writer on progress of document editing/QC process.
• Ensure references for clinical submission documents are procured with the appropriate copyright permissions and uploaded to VEEVA Vault RIM or similar repository
• Train internal and external stakeholders on editorial and QC best practices

Skills and experience you’ll bring:

• Strong understanding of complex medical and scientific content/data
• Extensive experience with copyediting, data integrity review, and source document verification
• Significant publishing experience using VEEVA Vault RIM or similar EDMS
• Expertise in Microsoft Office Suite (Word, Excel, and PowerPoint), Word toolbars/templates (StartingPoint, TransCelerate); SharePoint; Adobe Acrobat (Standard, Pro); and smartsheet or similar
• Experience with RightFind and reference citation software (EndNote, Reference Manager)
• Strong project management and time management skills
• Strong organizational skills and ability to prioritize tasks efficiently
• Excellent attention to detail
• Extensive familiarity with the AMA style guide
• Excellent written and verbal communication skills
• Strong knowledge of FDA/EMA/ICH guidelines and requirements and other standards, as applicable for clinical and regulatory documents
• Experience with regulatory submissions (eg, QC and formatting of eCTD modules per submission readiness standards and guidelines)

This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days/week in the office.