Medical Writing Associate
<h3><strong>Who we are:</strong></h3>
<p>Kymera is a clinical-stage biotechnology company pioneering the field of targeted 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 building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit <a href="https://www.kymeratx.com" target="_blank">www.kymeratx.com</a> or follow us on <a href="https://twitter.com/KymeraTx?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor" target="_blank">X (formerly Twitter)</a> or <a href="http://www.linkedin.com/company/kymeratherapeutics" target="_blank">LinkedIn</a>. </p>
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<h3><strong>How we work:</strong></h3>
<ul>
<li><strong>PIONEER</strong>: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.</li>
<li><strong>COLLABORATE</strong>: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.</li>
<li><strong>BELONG</strong>: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.</li>
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<h3><strong>How you’ll make an impact:</strong></h3>
<p>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.</p>
<ul>
<li>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.</li>
<li>Perform Quality Control reviews on clinical and regulatory documents against source data and establish and maintain QC assignment trackers and metrics.</li>
<li>Support document development and review processes, including KOMs, team roundtables, and study team reviews.</li>
<li>Develop/prepare/use established regulatory and medical writing internal checklists and best practices during editorial/QC review.</li>
<li>Ensure references for clinical submission documents are procured with the appropriate copyright permissions and uploaded to Veeva RIM or similar repository.</li>
<li>Train internal and external stakeholders on editorial and QC best practices.</li>
<li>Participate in process-improvement initiatives, SOP development and updates. </li>
</ul>
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<h3><strong>Skills and experience you’ll bring:</strong></h3>
<ul>
<li>At least 2 years’ experience in regulatory affairs, medical writing, or a similar function in a biotech/pharma setting</li>
<li>Experience with technical editing and formatting in MS word</li>
<li>Experience performing data integrity review and source document verification</li>
<li>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</li>
<li>Proficiency in understanding, critically analyzing, and interpreting data and summarizing complex results in a clear, concise, and scientifically accurate manner</li>
<li>Proficiency in researching and synthesizing scientific literature from various sources.</li>
<li>Strong organizational skills and ability to prioritize tasks efficiently</li>
<li>Ability to thrive in a fast-paced small company environment with an ability to balance competing priorities</li>
</ul>
<p>Preferred:</p>
<ul>
<li>Understanding and knowledge of FDA/EMA/ICH guidelines and requirements as applicable for clinical and regulatory documents</li>
<li>Experience with development of templates, processes, and procedures supporting the MW function.</li>
<li>Expertise in Microsoft Office Suite (Word, Excel, and PowerPoint), Word toolbars/templates (StartingPoint, TransCelerate); SharePoint; PleaseReview; Adobe Acrobat (Standard, Pro); and smartsheet or similar</li>
<li>Experience using VEEVA Vault RIM or similar EDMS</li>
</ul>
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<p>This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days/week in the office.</p>
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<div><em>Equal Employment Opportunity</em></div>
<p><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak">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.</span></p>
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<p><em><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak">Compensation</span></em></p>
<ul>
<li>Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.</li>
<li>The anticipated base salary range for this role is $85,000 – $130,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.</li>
<li>Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.</li>
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