Overview A global biopharmaceutical company on a mission to Solve On Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery development and commercialization of proprietary therapeutics Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology Oncology and Inflammation and Autoimmunity Headquartered in Wilmington Delaware Incyte has operations in North America Europe and Asia. Job Summary Primary function The Director Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical documents eg Investigators Brochures IBs Clinical Study Reports CSRs and marketing authorization submission documents accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous logically organized and have accurate data presentation and interpretation. While partnering with the Head of Medical Writing ensures the deliverables are resourced any issues are escalated and the strategic direction of the clinical documents for submission to regulatory authorities globally is sound. Keeps abreast of the clinical development of each of the compounds within the programs assigned and has functional understanding of global regulatory document standards. May have direct people management responsibilities. Reports to a Director of Medical Writing or above and if a people manager is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department. Essential Functions of the Job Key responsibilities Develop regulatory documents for submission to regulatory agencies globally in accordance with ICH and other global guidelines standards and processes as well as Incyte authoring standards as applicable in adherence with studyproject timelines and corporate objectives. Lead manage and coordinate all internal and external clinical medical writing activities associated with the preparation compilation and submission of applications to regulatory authorities globally for assigned programscompounds. Participate in cross-functional meetings to provide input regarding medical writing deliverables timelines and any processes needed for the completion of regulatory documents. Lead or participate in cross-functional process improvement initiatives. Serve as a subject matter expert eg document type process technology. Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents. Oversee contract medical writing resources as required to ensure timely completion of assigned projects which may include defining and reviewing of scopes of work content and financial within the assigned programs. May have direct people management responsibility of writers including providing mentoring and facilitating employee professional development. Serve as a member of the Medical Writing Leadership Team if a people manager helping to define the strategic direction and process improvements both within MW and cross-functionally. Qualifications Minimal acceptable level of education work experience and competency Bachelors degree required. Advanced degree in a relevant scientificclinicalregulatory field preferred. More than 10 years medical writing experience in the biopharmaceuticalCRO industry required. Demonstrated ability to understand and interpret clinical and scientific data ability to define data presentation to meet key messages developed by the clinical team. Excellent project management skills including in depth understanding of clinical timelines study and submission level and working knowledge of roles of other functional areas and the interdependencies among groups. Strong verbal written and interpersonal communication skills needed to work effectively in a team environment. Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired. Demonstrated ability to independently lead the clinical portions of a marketing authorization submission including the development review and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach. Proficient in MS Word. Working knowledge using an electronic document management system ability to use document templates ability to work with multiple document template styles and types. Ability to interact effectively with team membersleaders and senior leaders at Incyte proactively facilitating effective information exchangecommunication including problem solving and issue resolution. If direct people manager prior management experience preferred. Ability to manage people and provide active support in all aspects of the job. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access delete restrict edit move or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect how we use it whether collection and processing is optional sources of the personal data we process how it is shared where it is stored or transferred to how long we keep it and contact information for Incyte Incytes data protection officer and your supervisory authority if applicable. Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights. LI-MB1