Program Lead, Clinical Regulatory Writing, Vaccines
3 weeks ago
The Vaccine & Immune Therapies (V&I) unit has been created with the ambition to develop and deliver vaccines and antibodies that transform our ability to prevent and treat infectious disease. The creation and growth of this unit reflects AstraZeneca’s strong dedication to advance our transformative science for the benefit of patients worldwide. We are now recruiting a Program Lead, Clinical Regulatory Writing (CReW) professional. In this role you will provide authoritative leadership in one or several of our vaccine or antibody programs and partner with senior leaders to define and lead the global communications strategy. You will be a leader of clinical regulatory writing activities and people for V&I.
**Accountabilities**:
As a leader in V&I CReW you will be expected to provide experienced leadership across a group of submissions or programs, overseeing the communication strategy. You will drive the use and analysis of information by sharing drug and disease-specific knowledge and experience across program and submission teams. You will influence stakeholders at the highest levels of the organization, to establish the best communications practices across the TA. You will be setting clear directions while advising others and developing innovative solutions in highly complex situations.
**Essential Skills/Experience**:
- At least 8 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 Skills/Experience**:
- Ph.D in a scientific field with 10 years of proven experience.
- Extensive knowledge of the latest technical and regulatory expectations.
- Excellent organizational, analytical, decision-making, and interpersonal skills to lead complex projects simultaneously and to handle rapidly changing priorities.
- Established supervisory experience managing multiple direct reports or contract staff in a medical writing group or equivalent. Includes hiring, training, leading, and mentoring staff, setting goals within the function, and managing performance issues. Experienced in developing and overseeing and resource allocation.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. 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 groundbreaking methods and bringing unexpected teams together. This opportunity is available at our Barcelona (Spain), Waltham MA, (USA) Mississauga (Canada), Gaithersburg MD (USA), Gothenburg (Sweden) locations. Join us in our unique and ambitious world.
**Why AstraZeneca?**
We are a changemaker on the world stage at an exciting frontier of medicine. This is backed by deep knowledge and experience in our field. Building on this, we lead the way into the future with energy and drive. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises and to bring lasting immunity to people around the globe. We are committed to our central role in addressing pandemic and endemic diseases and ensuring our products continue to reach and benefit millions of people around the world.
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