Safety Writer – Contract

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $170 - $190 / hour

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

✏️ Content Writer

👻 Ghost score 8%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Author comprehensive safety assessment reports, including signal evaluations • Prepare and draft responses to FDA Information Requests • Prepare and draft core safety reference information or justification for safety sections of labels • Prepare and draft slides for safety-related presentations for internal and external meetings, including FDA advisory committee meetings • Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses • Contribute to risk-benefit analyses, RMP writing, and safety sections for clinical and safety documents, including IBs and CSRs • Assist in drafting, editing, formatting, and maintaining safety-related SOPs and work instructions • Ensure SOPs align with current regulatory requirements and internal quality standards • Support inspection readiness activities

🎯 Requirements

• Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field (doctorate level preferred) • 8+ years of medical writing/safety scientist experience, with significant focus in safety, clinical, or regulatory documents • Experience with writing safety signal assessment documents • Prior experience with writing and preparation for FDA advisory committees is highly valued • Demonstrated experience drafting responses to FDA Information Requests related to safety • Strong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management • Proven ability to review and interpret adverse event data • Familiarity with global regulatory requirements (EMA, PMDA, etc.)