Regeneron Pharmaceuticals Associate Editor in Tarrytown, New York
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 Associate Editor will work with more senior Medical Writing Editors and Medical Writers to learn about clinical regulatory documents and the drug development process. The individual will also work with more senior Medical Writing Editors to learn how to perform a full QC check of clinical regulatory documents, to ensure that they meet company standards and Health Authority guidelines. As the individual’s QC skills, knowledge of the drug development process and knowledge of regulatory document content increase, his/her responsibilities will increase to include more editing responsibilities (eg, checks for appropriate spelling/grammar, template use, and content).
• QC checks on Clinical Study Protocols and Clinical Study Protocol Amendments,
o This includes verifying consistency between the schedule of assessments and study description, ensuring consistency between the study schema and the schedule of events, and verifying references
• QC checks on Clinical Study Reports and Clinical Summaries,
o This includes verifying 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.
• QC checks on IBs and IB Updates,
o This includes verifying 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
• Work with senior Medical Writing Editors to learn about/train on the editing process
• Bachelor’s Degree or editor of life science (ELS) certification
• Bachelor’s degree and 1 years relevant industry experience
• A team player
• Eager to learn and easy to teach
• Able to follow meeting agendas, and, with appropriate guidance, produce quality work.
• Strong organizational, interpersonal and communication skills, as well as a good working knowledge of MS WORD and Adobe Acrobat.
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.