We are driven by a mission to deliver medical solutions that make a real difference for patients today while innovating for the future. Our work is guided by scientific rigor, strong ethics, and a commitment to improving global health. If you are passionate about transforming science into impactful medicines, this role offers an exciting opportunity to contribute.
About the Role
As a Nonclinical Scientific Writer, you will manage the preparation and submission of nonclinical documents to regulatory authorities in support of applications such as INDs, CTAs, NDAs, MAAs, and BLAs. Your expertise in scientific writing will ensure documents are clear, accurate, consistent, and compliant with international standards. You will collaborate with cross-functional teams to deliver high-quality documentation that supports successful regulatory submissions.
Key Responsibilities
*Prepare, review, and manage nonclinical summary documents for early development and marketing applications.
*Collaborate with regulatory and scientific teams to ensure comprehensive and accurate nonclinical dossiers.
*Work closely with project leaders and scientists to compose regulatory submission documents, study reports, and other research-related materials.
*Develop and maintain processes, tools, and guidelines for high-quality document production.
*Represent the nonclinical team in global initiatives focused on process and technology improvements.
Who You Are
*Hold a university degree in life sciences.
*Have several years of experience in scientific writing and editing within a nonclinical regulatory environment.
*Proficient in writing and editing software, with an interest in adopting new tools and technologies.
*Skilled at building trust and collaborating with diverse stakeholders.
*Committed to delivering high-quality documentation and meeting customer needs.
*Proactive, detail-oriented, and take ownership of your work.