Job Title: Sponsor Dedicated Sr Principal Medical Writer Overview The role of the Senior Principal Medical Writer will be to develop clinical documents for submissions to regulatory authorities globally. This includes overseeing medical writing activities, mentoring less experienced writers, and developing regulatory documents in accordance with ICH and other global guidelines. Responsibilities * Develop clinical documents for submissions to regulatory authorities globally. * Oversee medical writing activities of multiple compounds and serve as lead writer for individual summary documents. * Mentor and lead less experienced medical writers on complex projects as necessary. * Develop regulatory documents for submission to regulatory agencies globally, adhering to study/project timelines and corporate objectives. * Lead, manage, and coordinate internal and external clinical medical writing activities associated with preparation, compilation, and submission of applications to regulatory authorities globally. * Develop good working relationships with internal and external colleagues. * Participate in cross-functional process improvement initiatives. * Develop or support a variety of documents including: