We are seeking an independent and motivated Science Writer to focus on writing regulatory and compliance related documents. This individual will work with an interdisciplinary team to communicate important new scientific and clinical capabilities of the Tempus platform. The writer will have the opportunity to learn about clinical oncology, cutting-edge healthcare technology, and associated regulatory frameworks, all at a fast-growing biotechnology company.
What You’ll Do:
Work with our science, technical and legal teams to help:
- Prepare documents to submit to government and/or other regulatory bodies (e.g., FDA, CMS, etc.).
- Basic regulatory research and analysis.
- Generate tailored materials to inform or educate internal stakeholders (e.g., sales, marketing, other science/engineering teams), external clinical and research partners, and regulatory bodies.
- Manage document writing and review processes, including timelines for document generation, revision, and completion.
- Prepare technical documentation related to scientific publications.
- Bachelor’s degree in Biology or a similar field with significant scientific and other relevant writing experience, or Bachelor’s degree in English or a Communications field with significant exposure to scientific, medical, and/or technical disciplines.
- Experience and a successful track record in writing technical, compliance, and/or legal documents for a healthcare, technical and/or life science company.
- Strong project management skills.
- Ability to work in a fast-paced environment and adapt to changing business needs.
- Ability to read technical documents and translate them with an appropriate tone and level of detail to a range of audiences, including laypersons and experts.
- Excellent attention to detail.
- Masters or Ph.D. in a science discipline with writing experience preferred.
- Basic to intermediate knowledge of governmental regulatory processes and procedures in healthcare.
- Experience working with the FDA or other healthcare government bodies.
- Experience with/knowledge of cancer genomics including next generation sequencing, clinical oncology, bioinformatics and computational biology (machine learning, statistics, algorithms).
- Experience with Google Drive, and Microsoft Powerpoint, Excel, and Word.