Senior Manager or Associate Director, Medical Writing
<h3><strong>Who we are:</strong></h3>
<p>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. For more information about our science, pipeline, and people, please visit <a href="http://www.kymeratx.com">www.kymeratx.com.</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 contribute:</strong></h3>
<ul>
<li>Lead and/or manage the development of clinical and regulatory documents (eg, protocols and amendments, investigator brochures, and clinical study reports) with specific attention to document organization and quality, and adherence to Kymera standards and style</li>
<li>Distill scientific data in a clear and concise manner. Ensure consistent key messaging across documents, as appropriate</li>
<li>Provide strategic guidance on program/project teams regarding document and timeline development and resource planning</li>
<li>Facilitate effective roundtable discussions and record and communicate team-aligned decisions</li>
<li>Manage document review process, including scheduling of KOMs, team roundtables, and governance reviews, while implementing best practices</li>
<li>Manage external vendors (facilitate onboarding to Kymera standards and systems, review and revise [as needed] deliverables)</li>
<li>Lead or participate in process-improvement initiatives (eg, standard MW decks, new or updated SOPs)</li>
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<h3><strong>Skills and experience you’ll bring:</strong></h3>
<ul>
<li>BS/BA in the life sciences or related field and at least 5 years of clinical regulatory writing in biotech/biopharma</li>
<li>Demonstrated successful experience as a lead writer for clinical protocols, IBs, CSRs, and other clinical and regulatory documents.</li>
<li>Strong knowledge of FDA and ICH guidelines, GCP, and applicable US and international regulatory processes related to document preparation. Experience as contributing author for regulatory submissions is desired.</li>
<li>Experience with development and implementation of templates, processes, and procedures supporting the MW function.</li>
<li>Proficiency in understanding, critically analyzing, and interpreting data and summarizing complex results in a clear, concise, and scientifically accurate manner</li>
<li>Well-developed interpersonal skills, with experience interacting with and influencing people, and building strong positive relationships</li>
<li>Proficiency in researching and synthesizing scientific literature from various sources.</li>
<li>Experience with Microsoft Office Suite (Word, Excel, PowerPoint, and Project); Word toolbars/templates (StartingPoint, TransCelerate); SharePoint; Adobe Acrobat (Standard, Pro); EDMS (Veeva RIM); smartsheet; and PleaseReview</li>
<li>Experience with RightFind and reference citation software (EndNote, Reference Manager)</li>
<li>Strong project management and time management skills</li>
<li>Strong organizational skills and ability to prioritize tasks efficiently</li>
<li>Excellent attention to detail and strong written and verbal communication skills</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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<h3><strong>Skills and experience not an exact match?:</strong></h3>
<p>Go ahead and submit your resume (and a cover letter, if you’d like!). If this role isn't right for you, we can keep you in mind for future opportunities.</p>
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<p><strong><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">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></em></strong></p>
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