Medical Writer Job at Incyte USA
If you’re passionate about science communication and regulatory documentation, this Medical Writer Jobs opportunity could be your gateway into the pharmaceutical industry. Incyte Careers is offering an exciting role for a Medical Writer in Clinical and Quantitative Pharmacology, where professionals will contribute to regulatory submissions, clinical reports, and scientific documentation. For candidates looking for a Job opportunity for life science graduates, this role provides exposure to clinical research documentation and regulatory processes within a leading biopharmaceutical company. Those searching for a Job in USA in medical writing and regulatory affairs will find this opportunity both challenging and rewarding.
Company Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to address serious unmet medical needs in oncology, inflammation, and autoimmunity. The company is committed to rigorous research and development excellence with the goal of improving patient outcomes, advancing healthcare, and creating sustainable value. The organization strives to discover and develop both first-in-class and best-in-class medicines while advancing a diverse portfolio of large and small molecules.
Job Details:
- Job Title: Medical Writer, Clinical and Quantitative Pharmacology (CQP)
- Job ID: 5938
- Location: Wilmington, Delaware, United States
Medical Writer Job Summary
The Medical Writer, Clinical and Quantitative Pharmacology (CQP), is responsible for conducting quality reviews of clinical and nonclinical reports and summary documents that support global regulatory submissions. The role involves collaboration with multidisciplinary project team members to produce scientifically valid, complete, and consistent documents such as participant safety narratives, Investigator Brochures (IBs), nonclinical reports, and Clinical Study Reports (CSRs).
The position requires a general understanding of nonclinical and clinical research processes and global regulatory documentation guidelines. Strong organizational skills are essential, as the role involves managing quality control (QC) reviews of reports at multiple stages (e.g., initial QC review and confirmation of QC actions) across multiple projects and functional areas simultaneously.
Key Responsibilities
The Medical Writer will:
- Perform Quality Control (QC) proofreading and accuracy checks of clinical and non-clinical scientific reports and other project-related documents (e.g., Study Protocols, Pharmacometric Analysis Plans, and Statistical Analysis Plans).
- Conduct these QC activities within the EDMS and prepare QC review forms documenting observations made during report reviews.
- Manage the review and approval of QC review forms within the EDMS (Veeva Quality Suite).
- Assist in the development of regulatory documents for submission to global regulatory agencies, in accordance with ICH and other global guidelines, standards, processes, and company authoring standards.
- Ensure adherence to study or project timelines and corporate objectives while assisting with the collation and incorporation of review comments needed to finalize regulatory documents.
- Assist in maintaining QC task tracking tools and contribute to the development and refinement of QC and document workflow processes.
- Attend and participate in CQP and cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes required for the completion of accurate DMB and CPP reports and regulatory documents.
- Maintain current knowledge of industry trends and best practices in regulatory and scientific writing.
- Demonstrate willingness to learn basic concepts of preclinical and clinical pharmacokinetics.
- Perform other duties as assigned.
Qualifications (Minimum Education, Experience, and Competency)
- Bachelor’s degree in a relevant scientific, clinical, or regulatory field.
- At least one year of medical writing experience in the biopharmaceutical or CRO industry, or comparable experience in clinical or preclinical development.
- Ability to understand and interpret clinical and scientific data and effectively organize and communicate the information.
- Excellent organizational and time management skills.
- Strong verbal and written communication skills to work effectively within a team environment.
- Familiarity with regulatory requirements from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is preferred.
- Proficiency in Microsoft Word; experience with electronic document management systems and templates is considered an advantage.
