Associate Director / Director, Medical Writing Job at Incyte Corporation in Wilmin

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

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 study / project 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 programs / compounds.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) 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)

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.

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