Menu

Associate Director, Principal Medical Writer

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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 Sr Medical Writer develops clinical documents for worldwide submissions to regulatory authorities. The position 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.

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 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.

Administer 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.

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

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at:

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

 

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory... For full info follow application link.

 

We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

        

 

Copy Link

Job Posting: 847283

Posted On: Sep 22, 2021

Updated On: Oct 22, 2021