Scientific Writer Toxicology/DMB Job at Incyte Corporation in Wilmington

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

The Scientific Writer will be shared with the Toxicology and DMB departments and will be responsible for the development of nonclinical documents for submissions to regulatory authorities globally. The role 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 collaboration with Toxicology and DMB leads, in accordance with regulatory requirements. The writer ensures the timely delivery of high‑quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. The writer is responsible for the scientific writing activities of multiple compounds and serves as the lead writer for individual summary documents. The writer has a broad understanding of Toxicology and DMB scientific and clinical development processes and global regulatory document standards.

Key Responsibilities

• Develop nonclinical‑related regulatory documents for submission to regulatory agencies globally, in close collaboration with program tox and DMB leads, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable.
• 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

• 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.
• Proficient in MS Word or similar word processing software. Experience with an electronic document management system and templates is preferred.

EEO Statement

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