About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS. 

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way. 

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history.We all share the most important goal of bringing solutions to the PWS community. 

Summary of Job (brief description)

The Senior Manager, Medical Writing, is a key member of the Clinical Development organization responsible for independently authoring, managing, and delivering high-quality clinical documents across all phases of development. In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within Medical Writing, and oversees external writing resource. The Senior Manager, Medical Writing may also support scientific publication activities. This position will report to the Head of Medical Writing and function with moderate supervision.

Responsibilities

• Author and manage the development of clinical and regulatory documents including protocols, amendments, clinical study reports (CSRs), investigator brochures (IBs), and at times clinical modules of regulatory submissions.
• Collaborate cross-functionally with Biostatistics, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to ensure alignment of messaging and data accuracy.
• Provide project management oversight for writing deliverables across multiple programs, ensuring timelines and quality expectations are met.
• Drive process improvements, including developing and maintaining document templates, style guides, and best practices.
• Serve as a key partner in clinical development strategy planning, offering insight into document planning, messaging, and content structure
• Manage and oversee work outsourced to contract medical writers and CRO partners, ensuring high-quality deliverables.

Qualifications

• BS, MS, or PhD, PharmD in life sciences preferred.
• 5+ years of regulatory writing experience.
• Demonstrated capability to understand and summarize complex clinical data, and write and manage clinical study documents (eg, clinical study protocols, clinical study reports, and Investigator's Brochures).
• Strong understanding of ICH guidelines, GCP, and global regulatory requirements.
• Exposure to rare disease areas is preferred but not required.
• Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.
• Experience with document management systems (e.g., Veeva Vault)
• Proficiency in the Microsoft Office Suite.

Salary Range: $165,000 - $185,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)