Director, Clinical Regulatory Writing
hace 1 mes
.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.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 ExperienceEssentialLife 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.In depth knowledge of the technical and regulatory requirements related to the role.Extensive experience in clinical programs, study design and data analysis.DesirableAdvanced degree in a scientific discipline (PhD)
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.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...
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Director, Clinical Regulatory Writing
hace 7 meses
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 1 mes
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home. Job Description 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...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.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...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.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...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca A tiempo completoLocation: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home. 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...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España AstraZeneca A tiempo completoLocation: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home. Job Description 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...
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Associate Director, Clinical Regulatory Writing
hace 7 meses
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 6 meses
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 7 meses
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 Medical Writing Director
hace 4 semanas
Barcelona, Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completoAbout Our TeamWe are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.About the JobIn this role, you will be responsible for serving as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance, and ensuring that client objectives are met...
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Barcelona, España AstraZeneca GmbH A tiempo completoThis is what you will do:This position is accountable for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the NCCP writing activities across a disease area or set of clinical development programs. This position will function...
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Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: This position is accountable for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the NCCP writing activities across a disease area or set of clinical development programs. This position will...
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Program Lead, Clinical Regulatory Writing, Vaccines
hace 6 meses
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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Regulatory Affairs Director for Clinical Trials
hace 4 semanas
Barcelona, Barcelona, España Innovaderm Research A tiempo completoAbout Innovaderm ResearchInnovaderm Research is a leading organization in the field of clinical trials, and we are seeking an experienced Regulatory Affairs Director to join our team.
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Barcelona, España Astrazeneca Gmbh A tiempo completo.This is what you will do:This position is accountable for the timely preparation of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will support the operational and regulatory writing activities across the Alexion portfolio. This position will function...
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Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: This position is accountable for the timely preparation of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will support the operational and regulatory writing activities across the Alexion portfolio. This position will function...
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Managing Counsel
hace 6 meses
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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Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: This position is accountable for the timely preparation of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will support the operational and regulatory writing activities across the Alexion portfolio. This position will function...
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Medical Writing Team Lead
hace 3 días
Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completoCompany Overview: Syneos Health is a leading biopharmaceutical solutions organization accelerating customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Synergizing Clinical Development:We bring the customer and patient to the center of everything we do.We continuously...
