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 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.
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