Director, Nonclinical And Clinical Pharmacology Writing
hace 1 mes
This 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 with limited supervision.
You will be responsible for: Lead development and implementation of document strategy for NCCP regulatory documents, including, but not limited to, early-stage protocols, Investigator's Brochures, module 2 summaries for IND/CTA/NDA submissions.Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents.Author and manage high-quality NCCP MW in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross-functionally, negotiating timelines as necessary. May function as submission and/or program lead.Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.Mentor MW team members (internal and external), ensuring quality and efficiency in the production of NCCP regulatory documents.Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, quality, and safety colleagues.You will need to have: At least 10 years of regulatory MW experience authoring and leading global regulatory submissions.Demonstrated capability to summarize complex data and write regulatory documents.Excellent oral, written, and presentation skills; advanced user of MS Office suite.Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.Demonstrated aptitude for managing the work of external and/or internal medical writers, as well as training and fostering development of less experienced staff.Well-developed sense of ethics, responsibility, and respect for others.We would prefer for you to have: PhD or MS degree in life sciences or advanced degree in a relevant field.Broad experience with global clinical studies and regulatory submissions.Ability to establish excellent internal and external relationships with subject matter experts, alliance partners, and vendors.Skilled at planning, budgeting, and project management, as well as problem solving, organization, and negotiation.Experience in rare and ultra-rare diseases.Results-driven and with high standards of excellence for self and others.High level of flexibility and ability to innovate and adapt to changing conditions.
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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 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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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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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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Director, Clinical Regulatory Writing
hace 3 semanas
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 3 semanas
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, Medical Writing
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Barcelona, España Mymenopauserx, Llc 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 experienced Director, Medical Writing to drive the creation of high-quality clinical regulatory documents and support the development...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoJob 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...
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Director, Clinical Regulatory Writing
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoJob 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...
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Director, Clinical Regulatory Writing
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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 Gmbh 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...
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Director, Clinical Regulatory Writing
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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 3 semanas
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 3 semanas
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 3 semanas
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 3 semanas
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
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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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Director, Medical Writing
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Barcelona, España Mymenopauserx, Llc 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 development...
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Associate Director, Clinical Regulatory Writing
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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...
