The Drive to Discover. The Experience to Deliver.

Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.

Senior Medical Writer

Department: Development Operations
Location: Incyte Corporate Headquarters

Senior Medical Writer

This position 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 select clinical Module 2 summary documents.  The Senior Medical Writer may be responsible for the medical writing activities for one or more compounds and may contribute to major submissions.  Understands the clinical research processes and global regulatory document standards.  Demonstrates strong interpersonal and organizational skills and can interpret and describe results.  This position reports to the Head of Medical Writing.

Job Responsibilities

  • Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
  • Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
  • Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
  • Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
  • Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.
  • May participate in cross-functional process improvement initiatives.

Minimum Requirements 

  • A Bachelor's degree in life science discipline with Master's degree in life science discipline preferred.
  • At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
  • Understanding and knowledge of global regulatory requirements.
  • Knowledge of the various phases of clinical development required.
  • Proficiency in organizing and communicating clinical information required.
  • Strong communication, organizational, time management, and project management skills are required.
  • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
  • Proficient in MS Word.
  • Experience with an electronic document management system (eg, Documentum, Master Control) and templates is preferred.

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.

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System