Technical Writer - Kymera Therapeutics

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. 

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:

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.

• 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.

Skills and experience you'll bring:

Required:

• 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

Preferred:

• 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

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

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.