Incyte · 2 days ago
Scientific Writer Toxicology/DMB
Wilmington, DE
Full-time
Onsite
Mid LevelIncyte is a biopharmaceutical company focused on the discovery and development of novel medicines for oncology and inflammation. The Scientific Writer will be responsible for developing nonclinical documents for regulatory submissions, collaborating closely with project teams to ensure accurate and timely delivery of high-quality scientific writing.
BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
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
Qualification
Required
A degree in a relevant scientific/regulatory field is preferred, including Tox or DMB background. Equivalent experience or education will also be considered
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
Proficient in MS Word or similar word processing software
Preferred
Relevant experience in scientific writing within the biopharmaceutical/CRO industry or nonclinical development is preferred
Understanding and knowledge of FDA/EMA regulatory requirements preferred, but not required, to encourage diverse applicants who may bring other valuable skills and experiences
Experience with an electronic document management system and templates is preferred
Company
Incyte
Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.
Founded in 1991
1001-5000 employees
H1B Sponsorship
Incyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-01-16IPO
Leadership Team
Bill Meury
President & CEO
Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase