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.
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Learn more at: http://www.incyte.com/privacy-policy
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 here.
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