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: 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. Retirement Savings: Employees receive an automatic employer Pension contribution and can contribute to the Optional Savings Plan, which attracts an additional company match. Flexible Extras: We offer extras to support employees and the big moments in life. Vacation: a minimum of 4 weeks of paid vacation, pro-rated to your date of hire. Why Join Us? At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
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