Associate Director, Medical Writing

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

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.