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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The purpose of this position is to assist in the review and summary of clinical data for submission and publication purposes. In addition, this person may assist in the development and/or review of clinical study documents including but not limited to protocols, CRFs, IBs, DSURs, and study manuals as needed.
Support clinical oncology study teams with analysis of trends, safety and efficacy, quality check clinical data periodically and query issues
Review study related documents such as data management plan, eCRF completion guidelines, data validation manuals, database UAT
Draft and review clinical sections in regulatory and clinical documents such as study protocols, DSUR, investigator's brochure, PIP application, conference abstracts, slides for presentation
Assist with planning and setting up of meetings with external experts Ad board, consulting and steering committees
Writes and presents well-reasoned reviews and proposals to cross-functional project teams
Engage in team discussions and provide support for assigned projects
By collaborating with interdisciplinary teams, develop and optimize REGN's indication knowledge base/dashboard to facilitate information sharing across the organization
Must have an excellent understanding of oncology clinical data. Ability to conduct detailed review and analyses of clinical data and to generate queries as needed to ensure that we have data that is clean and submission ready. Must be resourceful and have outstanding abilities to synthesize and make connections
Assists in the development of portions of key documents for clinical programs
Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engages in team discussions and provides translational sciences support for assigned projects
Outstanding communication skills, both oral and written.
8-10 years in a clinical research environment.
Masters and/or PhD preferred.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.