Senior Clinical Editor
Click the Facebook, Google+ or LinkedIn icons to share this job with your friends or contacts. Click the Twitter icon to tweet this job to your followers. Click the link button to view the URL of the job, which then can be copied and pasted into an e-mail or other document.
Wilmington, DE 19803
Senior Clinical Editor
Incyte Corporate Headquarters
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 Sr Clinical Editor is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor copyedits, proofreads, formats, and verifies data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
Essential Functions of the Job (Key responsibilities)
- Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator’s Brochures, and Module 2 clinical summary documents) to ensure compliance with the Incyte Style Guide and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and Incyte style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
- Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Assist with publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
- Lead or participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
- May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
- Assist with training of more junior editors or contract staff.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 8+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing).
- Strong working knowledge of the editorial activities within Clinical Development.
- Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates. Experience with PowerPoint, Excel, Visio, Adobe preferred.
- Experience in the use of an EDMS (eg, MasterControl or Documentum-based system).
- Ability to effectively communicate with vendors and manage outsourced editorial work.
- Keen attention to detail.
- Ability to manage multiple activities, prioritize effectively, and work in a fast-paced, deadline-driven environment.
- Strong verbal, written, and interpersonal communication skills.
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.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.