Director, Medical Writing Xov385
Responder al anuncioEmpower 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 of our clinical portfolio. Your Impact:As a pivotal member of our team, you will:Strategize and Lead:Drive the development and execution of document strategies for regulatory submission, ensuring the highest quality of clinical study protocols, reports, and Investigator's Brochures. Collaborate and Contribute:Play a key role in developing briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents. Ensure Excellence:Author and manage outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines. Communicate Consistently:Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling. Mentor and Direct:Mentor and direct medical writing team members to ensure efficiency and quality in document production. Innovate and Collaborate:Develop effective partnerships within Alexion and with external stakeholders to maintain adherence to industry standards and regulatory requirements. What You Bring to the Table:Experience:At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise. Communication Skills:Exceptional oral and written communication abilities, with proficiency in MS Office. Regulatory Knowledge:A deep understanding of global regulatory requirements and ICH/GCP guidelines. Leadership:Proven experience managing and mentoring medical writers and fostering the development of junior staff. Professional Ethics:A strong sense of responsibility, ethics, and respect for others. Work Environment:Ability to work in an office environment, utilizing computers and participating in communication and collaborative activities during standard business hours. Preferred Qualifications:Education:PhD or MS degree in life sciences or an advanced degree in a relevant field. Relationship Building:Exceptional skills in establishing internal and external relationships, including with alliance partners and vendors. Project Management:Proficiency in planning, budgeting, and project management, coupled with strong problem-solving and negotiation skills. Specialized Experience:Knowledge of rare and ultra-rare diseases is highly advantageous. Drive and Excellence: A results-driven mindset with a commitment to high standards of excellence. What we offer:Flexible Health Benefits: A flexible benefits program for comprehensive health and dental care. #J-18808-Ljbffr
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