Medical Writer, Clinical and Quantitative Pharmacology

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 (Primary function)
The Medical Writer Clinical & Quantitative Pharmacology (CQP) is responsible for the quality review of clinical and nonclinical reports and summary documents supporting global regulatory submissions. Collaborates with multidisciplinary project team members, to write scientifically valid, complete, and consistent documents such as participant safety narratives, Investigator Brochures (IBs), nonclinical reports and CSRs. Has a general understanding of nonclinical and clinical research processes and global regulatory document guidelines. Good organizational skills are essential, as this position requires managing QC review of reports in multiple stages (e.g. initial QC review, confirmation of QC actions) supporting multiple projects and functional areas concurrently

Essential Functions of the Job (Key responsibilities)

• Perform Quality Control (QC) proofreading and accuracy checks of clinical and non-clinical scientific reports and other documents associated with the assigned project(s) (eg. Study Protocols, Pharmacometric Analysis and Statistical Analysis Plans), as appropriate, within the EDMS, prepare QC review forms documenting observations made during report QC review, manage review and approval of QC review forms in the EDMS (Veeva Quality Suite).

• Assist in development of regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives, and assist with collation and incorporation of review comments needed for the completion of regulatory documents.

• Assist with maintaining QC task tracking tools, and contribute to development and refinement of QC and document workflow processes

• Attend/participate in CQP and cross-functional meetings to provide input regarding medical writing deliverables, timelines, and process(es) needed for the completion of accurate DMB and CPP reports and regulatory documents .

• Maintain current knowledge of industry trends and best practices for regulatory and scientific writing.

· Willing to learn basic concepts of preclinical and clinical pharmacokinetics.

• Perform other duties as assigned.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor's degree required in a relevant scientific/clinical /regulatory field.

• At least 1 year of medical writing experience in the biopharmaceutical/CRO industry, or comparable experience within clinical or preclinical development.

• Ability to understand and interpret clinical and scientific data, as well as ability to organize and communicate the information.

• Excellent organizational and time management skills.

• Strong verbal and written communication skills needed to work effectively in a team environment.

• Familiarity with FDA/EMA regulatory requirements preferred.

• Proficient in MS Word. Experience with an electronic document management system and templates a plus.

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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