Associate Director/Director, Medical Writing

Incyte Corporation; Wilmington (DE); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Director of Medical Writing to oversee the development of critical clinical documents. This role involves ensuring the accuracy and quality of submissions to regulatory authorities, leading a team of writers, and participating in strategic initiatives to enhance the medical writing process. The ideal candidate will have extensive experience in medical writing and a strong understanding of regulatory requirements. Join a forward-thinking company committed to advancing innovative therapies and improving patient outcomes in oncology and inflammation. This is a unique opportunity to make a significant impact in the biopharmaceutical field.

Qualifications

• 10+ years of medical writing experience in biopharmaceutical/CRO industry.
• Strong project management skills with understanding of clinical timelines.

Responsibilities

• Develop regulatory documents for global submission according to ICH guidelines.
• Lead and manage clinical medical writing activities for assigned programs.

Skills

Medical Writing

Project Management

Data Interpretation

Communication Skills

Problem Solving

Education

Bachelor's Degree

Advanced Degree in Scientific/Clinical/Regulatory Field

Tools

MS Word

Electronic Document Management System

Job description

Overview

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)

• 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.