Director, Medical Writing
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.
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.
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.
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.
