Director, Nonclinical and Clinical Pharmacology Writing
hace 2 días
Job Title:Si desea conocer los requisitos para este puesto, siga leyendo para obtener toda la información relevante.Director, Nonclinical and Clinical Pharmacology Writing, BarcelonaClient:Alexion Pharmaceuticals, Inc.Location:Barcelona, SpainJob Category:OtherEU Work Permit Required:YesJob Reference:16329917447 Job Views:1Posted:23.07.2025Expiry Date: Job Description:Location:Barcelona, SpainJob Reference:R-211288Date Posted:06/23/2025Position Overview:This position is responsible for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. The role involves leading NCCP writing activities across disease areas or clinical development programs with limited supervision.Key Responsibilities:Develop and implement document strategies for NCCP regulatory documents, including protocols, Investigator’s Brochures, and module 2 summaries for IND/CTA/NDA submissions.Contribute to briefing packages, responses to health authority inquiries, and other submission documents.Author and manage high-quality NCCP medical writing, ensuring scientific accuracy, clarity, and regulatory compliance.Review documents prepared by others to ensure quality and adherence to standards.Mentor medical writing team members to ensure quality and efficiency.Maintain adherence to SOPs and regulatory requirements in collaboration with cross-functional teams.Qualifications:Minimum 10 years of regulatory medical writing experience with global submissions.Ability to summarize complex data and produce regulatory documents.Excellent communication, presentation, and Microsoft Office skills.Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.Experience managing internal and external medical writers and training staff.Strong ethical standards and professionalism.Preferred Qualifications:PhD or MS in life sciences or relevant field.Experience with global clinical studies, regulatory submissions, and rare diseases.Skills in project management, planning, and negotiation.Ability to adapt and innovate in changing environments.Additional Information:This role is primarily office-based. xsgfvud Candidates must be able to use a computer, communicate via phone and electronic messaging, and collaborate effectively during standard business hours.#J-18808-Ljbffr
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Director, Nonclinical and Clinical Pharmacology Writing
hace 1 semana
barcelona, España JR Spain A tiempo completoJob Title: Director, Nonclinical and Clinical Pharmacology Writing, Barcelona Client: Alexion Pharmaceuticals, Inc. Location: Barcelona, Spain Job Category: Other EU Work Permit Required: Yes Job Reference: Job Views: 1 Posted: Expiry Date: Job Description: Location: Barcelona, Spain Job Reference: R- Date Posted: 06/23/2025 Position Overview: This position...
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barcelona, España AstraZeneca A tiempo completoLocation: Barcelona, Spain (Hybrid Model) This role requires working from the office 03 days per week. This position is responsible for the timely preparation of high-quality, regulatory-compliant nonclinical and clinical documents in support of the clinical development portfolio at the Alexion Rare Disease Unit (Alexion). The role supports medical writing...
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Barcelona, España Alexion A tiempo completoLocation: Barcelona Spain (3 days/week working from the office)The Director CPQP position resides within Alexions Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead the incumbent is expected to provide subject matter expertise and program level functional leadership on issues related to clinical pharmacology, pharmacokinetics and...
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Barcelona, España Alexion A tiempo completoLocation: Barcelona Spain (3 days/week working from the office) The Director CPQP position resides within Alexions Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead the incumbent is expected to provide subject matter expertise and program level functional leadership on issues related to clinical pharmacology, pharmacokinetics...
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Director, Clinical PK/PD
hace 2 semanas
Barcelona, España Alexion A tiempo completoA biopharmaceutical company in Barcelona is looking for a Director CPQP. The role involves leading clinical pharmacology efforts and providing expertise on clinical trials from pre-clinical stages to registration. Candidates should have a doctoral degree and at least 10 years of relevant experience. Responsibilities include data analysis, regulatory...
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Director, Clinical Regulatory Writing
hace 6 días
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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Associate Director, Clinical Regulatory Writing
hace 6 días
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, Clinical Regulatory Writing
hace 1 semana
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 1 semana
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 Scientist Clinical Pharmacology and
hace 23 horas
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. The Senior...
