Director, Medical Writing

Built on a legacy of turning pioneering science into transformative treatments, we listen to and partner with the rare disease ecosystem to help improve outcomes for more people impacted by rare diseases across the globe.

Currently we are looking forDirector, Medical Writing accountable for the timely delivery of high-quality clinical regulatory-compliant documents supporting the clinical development portfolio at Alexion Rare Disease Unit.

Responsibilities

To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion’s continued compliance with laws, policies, regulations, and public commitments for transparency and disclosure.

The Alexion MW team provides expert leadership and strategic authoring of high-quality clinical and nonclinical regulatory documents. Alexion MW&CTT team supports Alexion’s core therapeutic areas in all phases of clinical development.

The Director, Alexion MW is expected to:

• Provide clear leadership and accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.
• 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.
• 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.
• Work in close collaboration with the MW team to drive best practices and support for innovation, capabilities, efficiency, and resourcing.
• Effectively influence stakeholders and colleagues at the highest levels within a project, eg, to establish best communications practices.
• Represent Alexion MW on cross-functional teams and advocate and train teams in submission excellence, high-performance authoring, and other best practices.
• Develop innovative best practices and improvement initiatives.
• Work independently and support the growth and development of the group by actively mentoring Alexion MW Associate Directors and Senior Managers and serving as a role model for the function.
• Have a broad knowledge of clinical development and the deliverables in scope for the function.

Qualifications

• Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry environment in positions with increasing levels of responsibility. Includes proficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions and extensive knowledge and experience relevant to multiple therapeutic areas, disease areas, and technical disciplines.
• Proven ability to advise and lead communication projects.
• Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives.
• In-depth knowledge of the technical and regulatory requirements related to the role.
• Conceptual and strategic thinker with strong networking skills.
• Extensive knowledge of the latest technical and regulatory documentation expectations desirable.
• 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.

Join Alexion and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in Rare Diseases. APPLY!

Date Posted

Closing Date

Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.