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 Scientific Writer would be shared with the Toxicology and DMB departments and will be responsible for the development of nonclinical documents for submissions to regulatory authorities globally. Provides Toxicology and DMB writing expertise to cross-functional project teams to ensure that Toxicology and DMB documents (eg, bioanalysis (BA), toxicokinetic (TK) and pharmacokinetic (PK) reports, Pharmacokinetics Written Summary (2.6.4) and Toxicology Written Summary (module 2.6.6), Health authority responses) accurately and consistently present key data-driven messages, in close collaborations with Toxicology and DMB leads, in accordance with regulatory requirements. Writes to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Responsible for the scientific writing activities of multiple compounds and serves as the lead writer for individual summary documents. Has a broad understanding of Toxicology and DMB scientific and clinical development processes and global regulatory document standards.
Essential Functions of the Job (Key responsibilities)
* Develop nonclinical-related regulatory documents for submission to regulatory agencies globally, in close collaborations with the program tox and DMB leads, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with Discovery and Development project timelines and corporate objectives.
* Manage scientific writing projects for GLP and non-GLP reports, including developing timelines (working with the project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
* Participate in Discovery and Development program and cross-functional meetings to provide input regarding scientific writing deliverables, timelines, and any process(es) needed for the completion of Toxicology and DMB- related regulatory documents.
* Review other documents associated with the assigned project(s) (eg, Pharmacometric analysis plans), as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
* A degree in a relevant scientific/regulatory field is preferred, including Tox or DMB background. Equivalent experience or education will also be considered.
* Relevant experience in scientific writing within the biopharmaceutical/CRO industry or nonclinical development is preferred.
* Proficiency in organizing and communicating Tox and DMB information required, working collaboratively with Tox and DMB leads.
* Strong organizational, time management, and project management skills are required.
* Excellent communication skills, including verbal, written, and interpersonal abilities, are needed to collaborate effectively in a team environment.
* Understanding and knowledge of FDA/EMA regulatory requirements preferred, but not required, to encourage diverse applicants who may bring other valuable skills and experiences.
* Proficient in MS Word or similar word processing software. Experience with an electronic document management system 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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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.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.
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