​​​

​​This position is accountable for thetimelypreparation of high-quality regulatory compliant clinical document deliverables for Alexion Rare Disease Unit (Alexion). This position will support the medical writing (MW) activities for one or more clinical programs.This position will function with supervision and guidance from experienced managersor colleagues​

​​PrincipalResponsibilities​

​​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 andnonclinicalregulatory documents.AlexionMW&CTT team supports Alexion’s core therapeutic areas in all phases of clinical development.

​The Specialist, Alexion MWis expected to:

• ​Support documentauthoring, ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practices are applied.

• ​Support document developmentbycontributingto strategic organization, clarity, accuracy, format, and scientific content

• ​Manageteamreviews,consolidatereviewercommentsandassist in reconciling feedback to support timely document finalization.

• ​Apply standardsusing approved templates, style guides, and standard processes to ensure document quality and compliance.

• ​Collaborate with team memberswithin medical writing andcross-functionally

• ​Support continuous improvementby contributing to teaminitiativesthat improve document preparation processes, templates, and quality practices.

• ​Contribute to delivery of the organization’sobjectivesbyidentifyingand adoptingappropriate AI-enabledways of working that improve efficiency, quality, compliance, and collaboration in document development.​

​​Qualifications

• ​​This is an entry-level position.Relevant experience in medical writing, clinical development, regulatory writing, scientific communications, ora related fieldisbeneficial.

• ​Demonstrated scientific writing, editing, and communication skills

• ​Ability to interpret scientific or clinical information and present it clearly and logically.

• ​Ability to work collaboratively in a matrix team environment

• ​Basic project management and organizational skills, including the ability to manage assigned work to timelines.

• ​DemonstratedproficiencyusingMicrosoft Office applications and standard document tools.

• ​Knowledge of drug development, clinical research, and regulatory documentation.​

​​Education​

• ​​Life Sciences degree inan appropriate discipline

• ​Advanceddegree(eg, MS, PhD, PharmD)in a scientific discipline is desirable​