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Role Summary
With an expanding regulatory team, an exciting opportunity has arisen for 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 a highly 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 or biologics, particularly cell and/or gene therapy, would be an advantage.
As Director, Medical Writing 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
Great News! We've discovered an exciting live job opportunity for a Director, Medical Writing position in United Kingdom. This job is currently open for hiring/recruiting by Autolus Limited, exclusively for you at UK Jobs. Feel free to download the job details here.
The work culture at Autolus Limited must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Autolus Limited and also by visiting their official website through Google.
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Yes, we found live job(s) for Autolus Limited in United Kingdom.
Director, Medical Writing jobs are available in United Kingdom.
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