The role
Paterna Biosciences is developing in vitro spermatogenesis, or IVS: a first-in-class biologic that grows functional sperm from a man’s own spermatogonial stem cells outside the body. Nothing like it has been through CBER, and we are building toward a Biologics License Application where no precedent exists. Our FDA submissions will live or die on the strength of their scientific argument. We need a writer who builds that argument from the literature.
This role requires the successful incumbent to be a highly skilled communicator, a scientist, and a subject matter expert in regulatory submissions. We seek compelling written communication skills as well as fluency in the reproductive biology and cell therapy literature. You need to read the reproductive biology and cell therapy literature with real fluency and write content that persuades a reader hunting for its weakest point. You will work under the direction of our Regulatory Strategist, who owns the regulatory strategy and supplies the FDA framing, and alongside our former FDA advisor.
What you will do
Craft the argument for advancing our product. Draft compelling scientific justification sections of our FDA submissions and meeting materials, including written correspondence pre-IND, and IND documents. Build from well-cited primary literature on spermatogenesis, spermatogonial stem cells, in vitro gametogenesis, and cell therapy. Lean on reviews and other secondary sources where they carry the argument further.
Turn data into defensible positions. Synthesize our internal scientific data and results into clear written arguments, including the justification for the methods we chose and for the alternatives we ruled out.
Write for a skeptical audience. Produce prose that holds up to a rigorous scientific and regulatory reader, with accurate citations and figures.
Find the gaps before FDA does. Surface where we lack data, justification, or content early enough that our research and development work can still fill it.
Work under regulatory guidance. Take FDA framing and formatting direction from the Regulatory Strategist and iterate quickly against tight review cycles.
Required experience and expertise
Scientific training. An MS or PhD in reproductive biology, cell or molecular biology, stem cell biology, or a closely related field are preferred but not required. We treat a bachelor’s degree plus five or more years of scientific or medical writing as equivalent.
Proven scientific writing. A record of IND, BLA, or NDA sections, published or unpublished papers, grants, SBIR applications, manuscripts, or review articles built on primary sources, in which the argument is clearly made and defended. Direct IND or BLA writing experience is highly preferred.
Rigor and speed. You will write for FDA reviewers who read for the weak point, so precision and citationdiscipline matter more than volume. Revisions come on tight cycles and attention to detail is a must.
Valuable, though not required
- Bench experience designing and running your own experiments, at any level including during your educational career.
- FDA submission writing experience, such as authoring 510(k), de novo, IND, or other modules for FDA review.
- Familiarity with regulatory writing conventions and structure.
- Ability to build publication-grade schematics and data figures, in BioRender, Illustrator, or equivalent. Background in andrology or reproductive medicine.
- Based in the Salt Lake City, UT area and available to work from our headquarters a few days a week. Strong candidates across the country will be considered for remote work.
About the role
We are open to part-time or full-time, employee or consultant, structured to fit the right person. Inquiries and introductions reach us at meredith.vadis@paternabio.com.
