Program Lead, Clinical Regulatory Writing, Vaccines

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

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.

  • Associate Director, Clinical Regulatory Writing

    hace 3 semanas

    Barcelona, España AstraZeneca A tiempo completo

    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 ground-breaking science for the benefit of patients worldwide. We are...

  • Director, Clinical Regulatory Writing

    hace 1 semana

    Barcelona, España Astrazeneca A tiempo completo

    .Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...

  • Director, Clinical Regulatory Writing

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Role holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...

  • Associate Director, Clinical Regulatory Writing

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications...

  • Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Role holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory...

  • Associate Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert communications leadership...

  • Director, Clinical Regulatory Writing

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    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...

  • Director, Clinical Regulatory Writing

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    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...

  • Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    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...

  • Senior Director, Clinical Regulatory Writing, Late

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    We are now recruiting a **Senior Director Clinical Regulatory Writing** (CReW) to lead the Late Respiratory and Immunology (Late R&I) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I, respectively. Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a...

  • Senior Director, Clinical Regulatory Writing, Late

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    We are now recruiting a **Senior Director Clinical Regulatory Writing** (CReW) to lead the Late Respiratory and Immunology (Late R&I) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I, respectively. Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a...

  • Senior Director, Clinical Regulatory Writing, Late

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    We are now recruiting a Senior Director Clinical Regulatory Writing (CReW) to lead the Late Respiratory and Immunology (Late R&I) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I, respectively. Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a...

  • Global Clinical Operations Program Director

    hace 3 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **About Biopharmaceutical Clinical Operations Vaccines and Immune Therapies** Do you have expertise in Clinical Operations, and a passion to support delivery of Clinical Development Programs? If yes, then we are recruiting for a key role within the Vaccines and Immune Therapies Clinical Operations group in AZ. BioPharmaceuticals Clinical Operations is a...

  • Global Clinical Program Lead, Late Stage

    hace 2 días

    Barcelona, España AstraZeneca A tiempo completo

    **Make a more meaningful contribution. Impact patients’ lives every day.**: Make a more meaningful impact in your career, with greater ownership and accountability to make a contribution. And in returnwe’re looking for people driven by making a difference to patients’ and society, dedicated to doing the right thing. **Do you have expertise in...

  • Director, Medical Writing

    hace 1 semana

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Empower the Future of Medicine at Alexion, AstraZeneca Rare Disease!Join our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases. We are seeking an experiencedDirector, Medical Writingto drive the creation of high-quality clinical regulatory documents and support the development...

  • Global Clinical Program Lead, Clinical Development

    hace 6 días

    Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in...

  • Global Clinical Program Lead

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Job Description: At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering lifechanging medicine is about being entrepreneurial finding those moments and recognizing their potential. Big success can come from seeing...

  • Global Clinical Program Lead, Late Stage

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Make a more meaningful contribution. Impact patients' lives every day.:Make a more meaningful impact in your career, with greater ownership and accountability to make a contribution. And in returnwe're looking for people driven by making a difference to patients' and society, dedicated to doing the right thing.Do you have expertise in Respiratory clinical...

  • Managing Counsel

    hace 3 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Managing Counsel** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

  • Director, Medical Writing

    hace 2 semanas

    Barcelona, Barcelona, España Alexion Pharmaceuticals A tiempo completo

    Empower the Future of Medicine at Alexion, AstraZeneca Rare DiseaseJoin our dedicated team at Alexion and contribute to our goal of providing life-changing therapies to patients dealing with rare diseases. We are currently looking for an experienced Director, Medical Writing to oversee the creation of high-quality clinical regulatory documents and support...