Director, Medical Writing Job at Atlas Venture in Waltham

• Company Address: 21 Hickory Drive, Suite 500, Waltham, MA, 02451

About Sionna Therapeutics

Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis.

Job Description

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.

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