This is what you will do: This position is accountable for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the NCCP writing activities across a disease area or set of clinical development programs. This position will function with limited supervision.
You will be responsible for: Lead development and implementation of document strategy for NCCP regulatory documents, including, but not limited to, early-stage protocols, Investigator's Brochures, module 2 summaries for IND/CTA/NDA submissions.Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents.Author and manage high-quality NCCP MW 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. May function as submission and/or program lead.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.Mentor MW team members (internal and external), ensuring quality and efficiency in the production of NCCP regulatory documents.Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, quality, and safety colleagues.You will need to have: At least 10 years of regulatory MW experience authoring and leading global regulatory submissions.Demonstrated capability to summarize complex data and write regulatory documents.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.We would prefer for you to have: PhD or MS degree in life sciences or advanced degree in a relevant field.Broad experience with global clinical studies and regulatory submissions.Ability to establish excellent internal and external relationships with subject matter experts, 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.
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