Medical Writing Associate

Kymera Therapeutics • Watertown, MA

6h • $85,000 - $130,000 • Hybrid

About The Position

The Medical Writing Associate will primarily be responsible for conducting and/or coordinating the editing, reviews and finalization of clinical and regulatory documents, including Clinical Study Protocols, Investigator’s Brochures, and Clinical Study Reports. This role may require collaboration across cross functional program teams to support the production of high-quality, strategically aligned documents in compliance with the regulatory requirements of a clinical development program, and with US or ex-US regulatory requirements. This is an excellent opportunity to develop or expand medical writing capabilities and expertise across a broad range of clinical and regulatory documents.

Requirements

• At least 2 years’ experience in regulatory affairs, medical writing, or a similar function in a biotech/pharma setting
• Experience with technical editing and formatting in MS word
• Experience performing data integrity review and source document verification
• Excellent attention to detail and strong written and verbal communication skills with a strong ability to understand and interpret complex medical and scientific content/data
• Proficiency in understanding, critically analyzing, and interpreting data and summarizing complex results in a clear, concise, and scientifically accurate manner
• Proficiency in researching and synthesizing scientific literature from various sources.
• Strong organizational skills and ability to prioritize tasks efficiently
• Ability to thrive in a fast-paced small company environment with an ability to balance competing priorities

Nice To Haves

• Understanding and knowledge of FDA/EMA/ICH guidelines and requirements as applicable for clinical and regulatory documents
• Experience with development of templates, processes, and procedures supporting the MW function.
• 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

Responsibilities

• Support the authoring and editing of clinical and regulatory documents (e.g., protocols and amendments, Investigator’s Brochures, CSRs, Briefing Packages) with specific attention to document organization and quality, and adherence to Kymera standards and style.
• Perform Quality Control reviews on clinical and regulatory documents against source data and establish and maintain QC assignment trackers and metrics.
• Support document development and review processes, including KOMs, team roundtables, and study team reviews.
• Develop/prepare/use established regulatory and medical writing internal checklists and best practices during editorial/QC review.
• 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.
• Participate in process-improvement initiatives, SOP development and updates.

Benefits

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $85,000 – $130,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 101-250 employees