Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including ophthalmology, hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
The Editor will work with senior Medical Writing Editors and Medical Writers to learn about clinical regulatory documents and the drug development process. The individual will also work with the team of Editors to learn how to perform a full quality checks of clinical regulatory documents, to ensure that they meet company standards and Health Authority guidelines. We are expecting the individual’s QC skills, knowledge of the drug development process and knowledge of regulatory document content increase, their responsibilities will increase to include more editing responsibilities.
In this role, a typical day might include the following:
- Review Clinical Study Protocols and Clinical Study Protocol Amendments,
- Verifying consistency between the schedule of assessments and study description, ensuring consistency between the study schema and the schedule of events, and verifying references
- Facilitate quality checks on Clinical Study Reports and Clinical Summaries,
- Reviewing consistency between hand-generated in-text tables and source tables, and between in-text numbers/ statements and source tables; ensuring consistency between discussion/ conclusion sections and results sections; and verifying reference, table, figure, and listing citations.
- Verify IBs and IB Updates,
- Checking consistency between hand-generated in-text tables and source tables, in-text numbers and source tables, in-text clinical summaries and Clinical Study Reports, and in-text non-clinical summaries and nonclinical reports
- Compilation, verification of content, formatting, and tracking of CSR appendices
This role might be for you if:
You have worked in the Life Science industry with a minimum of 1 year of sponsor experience
You are experienced with working on clinical related documents including CSRs, IBs, etc.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.