Director, Nonclinical and Clinical Pharmacology Writing
hace 2 semanas
Job 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 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. Candidates must be able to use a computer, communicate via phone and electronic messaging, and collaborate effectively during standard business hours. #J-18808-Ljbffr
-
Barcelona, España JR Spain A tiempo completoJob 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...
-
barcelona, España AstraZeneca GmbH 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...
-
Barcelona, España AstraZeneca A tiempo completo**Location**: Barcelona - Spain (3 days working from the office and 2 days working from home) **Introduction to role**: **Accountabilities**: As a Clinical Pharmacometrician, you will be accountable for expert data integration, analysis, interpretation, and reporting of M&S results at the study level. You will execute state-of-the-art M&S techniques with...
-
Nonclinical Submission Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completo**Nonclinical Submission Manager** **Barcelona, Spain** Make a more meaningful impact to patients’ lives around the globe Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world’s most...
-
Associate Director, Clinical Regulatory Writing
hace 1 semana
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...
-
Senior Scientist Clinical Pharmacology and
hace 2 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. The Senior...
-
Associate Director, Clinical Pharmacology and
hace 3 días
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona (on-site)** - Do you have experience in Project Management and thrive in an environment with collaboration and variation in you daily tasks where no day is the same as the previous? Do you also want to make a real impact bringing medicines to patients? If yes, this might be the next challenge for you!_ We have an exciting opportunity...
-
Director, Clinical Regulatory Writing
hace 6 días
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (3 days/week working from the office)** The 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...
-
Manager, Clinical and Regulatory Writing
hace 1 día
Barcelona, España AstraZeneca A tiempo completoIntroduction to role :This role is based in Barcelona with an on-site commitment of three days a week. Fluency in English is required.Are you ready to lead the charge in transforming breakthrough science into life-altering solutions? As a Manager in Clinical and Regulatory Writing you’ll be at the forefront of driving strategic communication excellence....
-
Mgr, Medical Writing
hace 5 días
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Manager, Medical Writing** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...