Technical Writer

Kymera Therapeutics - Watertown, MA

Full-time

Hybrid - Watertown, MA

Professional, Scientific, and Technical Services

About the position

The Technical Writer will primarily be responsible for conducting and/or coordinating the editing, reviews and finalization of clinical and regulatory documents, including Clinical Study Protocols, Investigator Brochure's, Regulatory Briefing Books and Meeting Requests, and components of INDs and CTAs. This is an excellent opportunity to develop or expand technical writing and editing capabilities and expertise around a broad range of clinical and regulatory documents.

Responsibilities

• Edit clinical and regulatory documents for correct formatting, consistency and clarity.
• Author and/or edit internally written nonclinical study reports to support regulatory submissions.
• Perform Quality Control reviews on clinical and regulatory documents against source data and establish and maintain QC assignment trackers and metrics.
• Develop/prepare/use established regulatory and medical writing internal checklists and best practices during editorial/QC review.
• Initiate and manage document review workflows and approvals in Veeva RIM.
• Provide technical and editorial support to lead medical and regulatory writers for clinical and regulatory documents and dossiers.
• Ensure references for clinical submission documents are procured with the appropriate copyright permissions and uploaded to Veeva RIM or similar repository.
• Train internal and external stakeholders on editorial and QC best practices.

Requirements

• 2-5 years experience in regulatory affairs, medical writing or similar in a biotech/pharma setting
• Excellent attention to detail and written communication skills with a strong ability to understand and interpret complex medical and scientific content/data
• Experience with technical editing and formatting in MS word
• Experience performing data integrity review and source document verification
• Strong project and time management skills with proven ability to prioritize multiple competing priorities in a fast past environment
• Strong organizational skills and ability to prioritize tasks efficiently
• Understanding and knowledge of FDA/EMA/ICH guidelines and requirements as applicable for clinical and regulatory documents

Nice-to-haves

• Expertise in Microsoft Office Suite (Word, Excel, and PowerPoint), Word toolbars/templates (StartingPoint, TransCelerate); SharePoint; PleaseReview; Adobe Acrobat (Standard, Pro); and smartsheet or similar
• Experience using VEEVA Vault RIM or similar EDMS