Who we are:
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.
How we work:
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PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
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COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
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BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll contribute:
The Associate Director, Medical Writing will collaborate within cross functional program teams to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
- Lead and/or manage the development 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
- Provide strategic guidance to program/project teams for document timeline development and resource planning
- Manage external medical writing vendors including facilitating onboarding to Kymera standards and systems and acting as the conduit from internal to external teams
- Facilitate effective roundtable discussions and record and communicate team-aligned decisions
- Manage document development and review process, including KOMs, team roundtables, and governance reviews
- Lead or participate in process-improvement initiatives, SOP development and updates.
Skills and experience you’ll bring:
- BS/BA in the life sciences or related field and at least 5 years of clinical regulatory writing in biotech/biopharma.
- Demonstrated successful experience as a lead writer for clinical protocols, IBs, CSRs, Module 2 summaries and other clinical and regulatory documents.
- 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.
- Experience with development and implementation of templates, processes, and procedures supporting the MW function.
- Proficiency in understanding, critically analyzing, and interpreting data and summarizing complex results in a clear, concise, and scientifically accurate manner.
- 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
- Experience with RightFind and reference citation software (EndNote, Reference Manager)
- Well-developed interpersonal skills, with experience interacting with and influencing people, and building strong positive relationships.
- Ability to thrive in a fast-paced small company environment with an ability to balance competing priorities.
- Strong project management skills.
- Excellent attention to detail and strong written and verbal communication skills.
This position is based in Watertown, MA, and offers a hybrid work model
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.
