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Director, Clinical Regulatory Writing
1 month ago
Join us at AstraZeneca, where we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. Our exceptional team is working on the groundbreaking area of cellular therapies, and we are investing in internal capabilities to discover and accelerate the delivery of next-generation cellular therapies for patients. As part of our Clinical Regulatory Writing team, you will play a crucial role in bringing these transformative therapies from the lab to life.
We are now recruiting a Director, Clinical Regulatory Writing (CReW), Immunology Cell Therapy Program Lead. In this role you will provide expert leadership to the delivery of the product pipeline through partnering with senior leaders to define and lead the global communications strategy. You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners.
This opportunity is available at our Boston Seaport, MA (USA) location.
We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote-based working.
The Director, CReW, develops communications strategies to guide programs while advocating and developing best practices for document and accelerated submission delivery, represents strategic communications expertise in business process optimisation and improvement initiatives, and supports the growth and development of internal talent.
What You will Do
As a leader in CReW you will be expected to:
- Provide expert leadership across a group of submissions or programs, overseeing the communication strategy and driving the authoring of large clinical submission packages and other complex clinical documents, aligned with project development plans, regulatory requirements, and communications best practices.
- Manage and prioritize multiple projects in parallel, often working under accelerated timelines to deliver.
- Be a proactive, independent, and innovative leader of large, complex, matrix teams. Effectively influence stakeholders and colleagues at the highest levels of a program to establish best communications practices.
- Delegate and empower other internal and external writers, and ensure relevant regulatory, technical, and quality standards are achieved and the appropriate processes and best practice are applied.
- Be relentless in pursuit of excellence, personally driven to improve standards across the business and provide relevant support and training to projects and vendors, as required. Recognize opportunities and spearhead improvement initiatives at the Therapy Area or company-wide level.
- Support the growth and development of the CReW community by actively mentoring less experienced writers and serving as a role model for the function. Peer review, remove obstacles and proactively identify and mitigate risks.
- Represent Clinical Regulatory Writing on various improvement workstreams, business initiatives, and external activities and meetings by acting as a subject matter expert.
- Drive resourcing strategy within area of accountability. Directly interface with medical writing vendors in contracting and overseeing externalized work.
- CReW Program Leads in this role may also be line managers, accountable for coaching and mentoring direct reports fairly and providing strategic direction and highlighting new opportunities at the individual and departmental level.
Essential for the Role:
- Bachelor's degree in life sciences or equivalent
- Extensive experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organisation environment, particularly in Immunology Cell Therapy.
- Excellent organizational, analytical, decision-making, and interpersonal skills to manage complex projects simultaneously and to handle rapidly changing priorities.
- Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives.
- Experience in leading large, diverse, matrix teams.
- Excellent verbal and written communication skills in English.
- Conceptual and strategic problem-solving ability with strong networking and influencing skills.
- Flexibility in adapting to changing circumstances and latest information.
Date Posted
23-Jul-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.