Senior Medical Writer

Senior Medical Writer

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 Senior Medical Writer is responsible for the development of clinical documents for worldwide submissions to regulatory authorities. Works directly with multidisciplinary project team members with the goal of independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator's brochures (IBs), and collaborating on clinical summary documents. Demonstrates strong interpersonal and organizational skills and can interpret and describe results. Responsible for the medical writing activities for one or more compounds. Understands the clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above.

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, and Company authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Administer as appropriate the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg. Protocols and Statistical Analyses Plans), as appropriate.
• May participate in cross-functional process improvement initiatives.
• Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor's degree required or equivalent experience. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• Proficient in MS Word. Experience with an electronic document management system and templates is preferred.
• Understanding of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development preferred.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a collaborative environment.
• Proficiency in organizing and communicating clinical information required with minimal oversight.
• Strong organizational, time management, and project management skills are required.
• Medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.

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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