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Director, Medical Writing

Sionna Therapeutics is a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF) by normalizing the function of CFTR, the key protein associated with disease progression in CF. Building on over a decade of extensive research on the genetic mutations associated with CF and founded in 2019, Sionna is advancing a pipeline of small molecules engineered to correct the protein defects caused by ΔF508, the most common mutation that affects the CFTR protein. The company has a first-in-class portfolio of programs targeting correction of NBD1, the key and unique mechanism to enable full restoration of ΔF508-CFTR function, and complementary programs targeting ICL4 and TMD1. Sionna’s pipeline has the potential to deliver best-in-class efficacy and reach previously unachievable levels of long-term benefit for people with CF.

Position Summary 

Sionna Therapeutics is seeking an experienced, self-motivated medical writing professional to provide technical and medical writing support in a variety of areas, including but not limited to CMC, non-clinical, clinical, and administrative regulatory submissions. The person in this role will work with medical writing consultants and vendors and lead the authoring, reviewing, QC and approval of clinical documents (e.g. protocols, IBs, CSRs) and regulatory documents (e.g. DSURs, briefing books), as well as support the creation of templates and SOPs that may be required to guide the life cycle management of medical and regulatory documents while ensuring consistency across documents.

We are accepting resumes for the position at careers@sionnatx.com.

Key Responsibilities:

  • Lead internal and vendor medical writing activities including the authoring, review and approval of regulatory and clinical documents; these documents include protocols, protocol amendments, protocol synopses, schematics, study reports, investigator brochures, annual safety reports, IND/IMPD clinical sections, Module 2 summaries, briefing books, regulatory responses, and other documents as necessary in CTD format under tight timelines.
  • Participate in the creation of the strategy driving these deliverables.
  • Provide expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure high-quality deliverables.
  • Ensure efficient formatting of documents and a consistent style of presentation to maintain quality and ease of review across multiple documents.
  • Create best practices of medical writing for the development organization.
  • Overall responsibility for planning, implementing, and adhering to medical writing timelines and budgets.
  • Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in IND/NDA/MAA submission planning and documentation.
  • Act as Lead Medical Writer, where needed.
  • Work cross-functionally with external partners and the broader organization.
  • Create and manage document templates and the style guide; help support identification and use of document reviewing/authoring tools, if needed
  • Develop and participate in department training and SOP development.
  • Perform reviews of medical writing deliverables, as well as reviews of statistical deliverables such as tables, figures, and listings, as needed.
  • Maintain knowledge base of current developments in the medical writing field and related technologies.
  • Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections, where needed.
  • Over time, build an in-house capability, leveraging external resources as needed as the company’s pipeline and business needs develop.
  • Additional tasks and responsibilities as required.

Experience, Education, and Qualifications:  

  • 10+ years in Medical Writing or related field within the Pharmaceutical/Biotech industry.
  • Bachelor’s Degree required; advanced degree preferred.
  • IND/NDA/MAA experience.
  • Ability to work in a small organization, multitask with changing priorities, and manage tasks in a fast-paced environment.
  • Strong vendor and in-house team management experience.
  • Experience and skill performing medical literature searches a plus.
  • Excellent communication skills, both written and verbal.
  • Excellent organizational skills and ability to work independently.