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. Our extended benefits include prescription drugs, vision care, fertility treatment, support for gender affirmation procedures as well as other health and mental health options.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. From great maternity, parental and adoption leave support, to increased paid bereavement days, and our 12-week top-up for compassionate and critical illness leave.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.
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