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Director, Clinical Regulatory Writing
hace 6 días
.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 clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company's core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.The Clinical Regulatory Writing Director provides expert communications leadership for the most complex and business-critical clinical activities by driving strategic content development in alignment with product strategy and communications excellence.The Clinical Regulatory Writing Director is encouraged to:* Lead large, complex teams delivering business needs of the highest priority, while delegating to and empowering colleagues to undertake tasks and assignments.* Lead development of the clinical submission communication strategy (cSCS) for complex and/or business critical submissions.* Review across clinical regulatory documents for internal consistency and alignment while ensuring relevant regulatory, technical and quality standards are achieved and relevant processes and best practice are applied.* Lead clinical-regulatory authoring teams during the regulatory response period up through approval.* Effectively influence stakeholders and colleagues at the highest levels within a project, eg, to establish the best communications practices.* Represent Clinical Regulatory Writing on cross-functional teams and advocate and train teams in authoring and review best practice.* Develop innovative best practices and improvement initiatives to support the skill.* Work independently and support the growth and development of the group by actively mentoring Clinical Regulatory Writing Associate Directors and Managers and serving as a role model for the function.* Have a broad knowledge of clinical development and the deliverables in scope for the function.Education, Qualifications, Skills and ExperienceEssential* Life Sciences degree in an appropriate discipline.* Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment* Ability to advise and lead communication projects* Understands drug development and communication process from development, launch through life cycle management
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Director, Clinical Regulatory Writing
hace 3 semanas
Barcelona, España AstraZeneca A tiempo completoRole 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...
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Director, Clinical Regulatory Writing
hace 2 semanas
Barcelona, Barcelona, España AstraZeneca A tiempo completoRole 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...
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Associate Director, Clinical Regulatory Writing
hace 3 semanas
Barcelona, España AstraZeneca A tiempo completoRole 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...
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Associate Director, Clinical Regulatory Writing
hace 2 semanas
Barcelona, Barcelona, España AstraZeneca A tiempo completoRole 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...
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Associate Director, Clinical Regulatory Writing
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoThe 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...
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Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoAt 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...
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Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoAt 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...
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Senior Director, Clinical Regulatory Writing, Late
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoWe 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...
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Senior Director, Clinical Regulatory Writing, Late
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoWe 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...
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Senior Director, Clinical Regulatory Writing, Late
hace 2 semanas
Barcelona, Barcelona, España AstraZeneca A tiempo completoWe 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...
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Director, Clinical Regulatory Writing
hace 2 semanas
Barcelona, Barcelona, España AstraZeneca A tiempo completoAt 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...
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Director, Medical Writing
hace 2 semanas
Barcelona, Barcelona, España Alexion Pharmaceuticals A tiempo completoEmpower 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...
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Director, Medical Writing
hace 6 días
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...
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Director, Medical Writing
hace 2 meses
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-198924 Date posted: 05/06/2024 **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 experienced **Director, Medical Writing** to drive...
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Director, Medical Writing
hace 8 horas
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-198924 Date posted: 05/06/2024 **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 experienced **Director, Medical Writing** to drive...
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Program Lead, Clinical Regulatory Writing, Vaccines
hace 3 semanas
Barcelona, España AstraZeneca A tiempo completoThe 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...
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Director, Medical Writing
hace 2 semanas
Barcelona, Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, SpainJob reference: R-198924Date posted: 05/06/2024Empower the Future of Medicine at Alexion, AstraZeneca Rare DiseaseJoin our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases. We are seeking an experienced Director, Medical Writing to drive the creation of...
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Senior Manager Medical Writing
hace 2 semanas
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-199878 Date posted: 05/16/2024 **This is what you will do**: This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (MW) activities for one or more clinical programs. This position...
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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...
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Director, Medical Writing
hace 1 mes
Barcelona, España Alexion Pharmaceuticals A tiempo completoEmpower 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 experienced Director, Medical Writing to drive the creation of high-quality clinical regulatory documents and support the...