What are the responsibilities and job description for the Director, Medical Writing position at Atlas Venture?
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.
- 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.
Experience, Education, and Qualifications :
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