Job Description

Director, Medical WritingWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. Thatxe2x80x99s why we work, on average, a minimum of three days per week from the office. But that doesnxe2x80x99t mean wexe2x80x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.This position is accountable for the timely delivery of high-quality clinical regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with minimal supervision.You will be responsible for:

• Lead development and implementation of document strategy for clinical regulatory submission documents and other clinical documents including clinical study protocols, clinical study reports, Investigator's Brochures, and clinical Common Technical Document components (eg, Module 2 summaries).
• Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents.
• Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross functionally, negotiating timelines as necessary.
• Support consistent messaging across all submission documents (nonclinical, clinical, and product labeling).
• Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
• Direct and mentor MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents.
• Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues.
• Develop effective collaborations with other functional lines within Alexion, and externally with regulatory, industry, professional, and academic organizations.

You will need to have:

• Excellent oral, written, and presentation skills; advanced user of MS Office suite.
• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
• Demonstrated aptitude for managing the work of external and/or internal medical writers, as well as training and fostering development of less experienced staff.
• Well-developed sense of ethics, responsibility, and respect for others.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.
• Ability to establish excellent internal and external relationships, including alliance partners and vendors.
• Skilled at planning, budgeting, and project management, as well as problem solving, organization, and negotiation.
• Experience in rare and ultra-rare diseases.
• Results-driven and with high standards of excellence for self and others.
• High level of flexibility and ability to innovate and adapt to changing conditions.

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.#LI-HybridDate Posted 25-Mar-2025Closing Date 07-Apr-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

AstraZeneca