Director, Clinical Regulatory Writing
hace 7 meses
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
We are now recruiting a **Director, Clinical Regulatory Writing** (CReW). I**n this role you will provide expert leadership to the delivery of the CVRM 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), Barcelona (Spain) **or **Bangalore (India)** locations**. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.**
Director CReW develops communications strategies to guide these programs while advocating and developing best practices for document and accelerated submission delivery, representing strategic communications expertise in business process optimisation and improvement initiatives, and supporting the growth and development of internal talent
**What You’ll Do**
As a leader in CVRM CReW you will be expected to:
- Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other complex clinical documents that are aligned with project development plans, regulatory requirements, and communications best practices.
- Create robust clinical arguments through strong analytical and communications skills and critically evaluate clinical trial designs.
- Be a proactive, independent, and innovative leader of large, complex teams.
- 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.
- Effectively influence stakeholders and colleagues at the highest levels of a program to establish best communications practices.
- Relentless in the pursuit of excellence, driven to improve standards across the business. Recognize opportunities and spearhead improvement initiatives at the TA or company-wide level.
- Support the growth and development of the CVRM CReW community by actively mentoring less experienced writers and serving as a role model for the function.
- Manage and prioritize multiple projects in parallel, often working under accelerated timelines to deliver.
**Essential for the Role**:
- At least 6 years of proven experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment.
- Broad cross-functional understanding of the drug development process from scientific, technical and business perspectives.
- Experience in leading large, diverse 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 or new information.
**Desirable Qualifications**:
- Ph.D in a scientific field with 8 years of proven experience.
- Extensive knowledge of the latest technical and regulatory expectations.
- Excellent organizational, analytical, decision-making, and interpersonal skills to manage complex projects simultaneously and to handle rapidly changing priorities.
**Why AstraZeneca?**
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.
**Where can I find out more?
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