Job Description

We seek high-performing team members who are skilled, proactive, and solutions-oriented individuals who take initiative, embrace challenges, and are motivated to advance new therapies. At Cugene, employees contribute directly to shaping R&D, translational and clinical strategies, working collaboratively to move innovative science from the lab into the clinic.

ROLE DESCRIPTION

Support preparation and submission of key regulatory and research documents. We are seeking a Medical Writer who has demonstrable experience in writing, reviewing, and editing Pre-IND and IND dossiers and research manuscripts. Reporting directly to the EVP of R&D and working closely with the project and functional research leads, the candidate will also be expected to support the review and editing of clinical study plans and clinical study reports. The ideal candidate should have the ability to understand, interpret, and synthesize data from immunological and/or immuno-oncology studies; thus, a scientific degree or research experience in these fields is highly preferred. A well-rounded candidate should also be capable of implementing a robust documentation system to centralize pre-clinical and clinical documents for regulatory submissions.

KEY RESPONSIBILITIES

Write high-quality PIND/IND reports, including the Investigator’s Brochure, Clinical Study Plan, preclinical/nonclinical summary reports, and research manuscripts. Work with functional research leads to interpret complex data and translate findings into clear, concise, and accurate study reports and research manuscripts. Work closely with project leads to design and execute timelines for deliverables (e.g., study reports, manuscripts), including structured documentation review processes involving both internal and external stakeholders. Create and standardize templates for research manuscripts. Coordinate internal and external review cycles with research teams and medical writers to finalize clinical study reports and maintain up-to-date regulatory documents. Lead the quality control and peer-review processes of core deliverables prior to regulatory submissions. Ensure all PIND/IND and clinical dossier documents meet ICH/FDA regulatory standards. Maintain consistency in scientific messaging across all regulatory and research reporting materials.

QUALIFICATIONS AND EXPERIENCE

MS required; PhD desirable. At least 8-10 years of scientific and medical writing experience. Excellent ability in interpreting complex immunological/immuno-oncology data and translating data into high-quality reports for technical and regulatory audiences. Proven ability to lead document review cycles, resolving comments, and managing documentation and submission processes. Excellent editing and quality control skills with rigorous attention to details. Ability to work under tight timelines and manage multiple deliverables simultaneously. #J-18808-Ljbffr ClinLab Staffing

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