Medical Writing Associate

Role Summary

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.

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.

Qualifications

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

Skills

• Proficiency in MS Word and data integrity review
• Strong written and verbal communication; ability to interpret complex medical content
• Ability to research and synthesize scientific literature
• Strong organizational skills and prioritization

Education

• No specific education requirement specified in source

Additional Requirements

• Location: Watertown, MA; hybrid model with a minimum of 3 days/week in the office