Director, Medical Writing

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 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)

• Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.  
• More than 10 years medical writing experience in the biopharmaceutical/CRO 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 members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (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.

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