Associate Director/ Director - Medical Writing Regulatory Affairs

Vacancy for Associate Director/ Director - Medical Writing Regulatory Affairs
Location:
UK - White City, West London & Hybrid
Job SummaryRole SummaryWith an expanding regulatory team, an exciting opportunity has arisen for an Associate Director or a Director to join the Autolus Regulatory and Medical Writing team to support global expansion of our cell and gene therapy products. This position requires a medical writing professional with a proven track record of successfully working as a collaborative and strategic partner to cross-functional colleagues in a biotech/pharmaceutical environment. We are looking for an experienced writer who understands the principles of scientific and regulatory writing, how to write with the audience in mind, and can analyse, interpret, and distil data and other information to create clear and concise messaging in regulatory documents. Experience with immuno-oncology, auto-immune therapies, or biologics, particularly cell and/or gene therapy, would be an advantage. In this role, you will be primarily responsible for the development of timely and high quality scientific, clinical, and safety documentation required for submission to regulatory authorities in close collaboration with cross-functional colleagues. You will independently lead the authoring of complex medical writing deliverables such as clinical study reports, nonclinical and clinical components of INDs/CTAs, BLAs/MAAs, information requests/response to questions, briefing documents, PIPs/PSPs, investigator brochures, and protocols. You will leverage experience, scientific, and operational expertise, as well as matrix leadership skills to drive document strategy with the cross-functional team. You will ensure document consistency, regulatory compliance, and high quality for all responsible deliverables. You will track milestones and deliverables to support the Head of Medical Writing manage business priorities. You will also contribute to key organizational process improvements, including process and/or training gap analyses and identifying possible solutions to support excellence in medical writing at Autolus. This is a highly visible role in a growing company, providing the opportunity to lead key activities to support career progression.Key Responsibilities• Independently author, review, and lead the production of high quality, complex medical writing deliverables, such as clinical study reports, nonclinical and clinical components of INDs/CTAs, BLAs/MAAs, investigator brochures, and protocols• In collaboration with the regulatory affairs team, co-author or lead the production of high quality documents for health authorities (eg briefing books, responses to questions, PIPs/PSPs), as well as adhoc regulatory documents• Proactively lead or oversee complex writing projects including that for regulatory submissions, including managing timelines and resources (including internal and external resources) and ensuring those timelines are met• Serve as the functional area lead on project teams and proactively drive document strategy. Contribute to key messaging, content, format, and consistency, as well as ensuring compliance of documentation to internal company standards and external regulatory guidelines.• Input into planning of data analyses and drives decision making for data presentation strategies to support advance planning of clinical study reports, submission documents and/or answers to questions. Engage early with project teams and subject matter experts to plan and review statistical analysis plans, as well as tables, listings, and figures• Organize and lead functional and cross-functional document planning, strategy, comment adjudication, or other team meetings• Provide writing strategy for overall product development, tracking milestones and medical writing deliverables, to inform resourcing, forecasting, budget, and prioritisation• Lead or contribute to the development of medical writing and quality control style guides and processes, as well as medical writing and wider department initiatives. Own and maintain relevant document templates. Identify process and/or training gaps and possible solutions to advance core competency and skill set for all Autolus team members authoring or contributing to clinical and regulatory documents• May manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands• Maintain subject area expertise related to the company’s development products, disease indications, and regulatory guidelines• Willingness and flexibility to perform miscellaneous job-related duties and additional duties and responsibilities, as assigned
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