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.
SUMMARY: The Lead Editor will ensure the highest document and editorial standards through in-depth edit and QC checks of all Medical Writing documents. This individual will work independently as an Editor for Documents such as CSRs, CSPs, CSR amendments, IB and IB updates, and Clinical Summaries in a variety of Therapeutic Areas. This individual will be asked to help create/write parts of documents (CSRs, protocols, summary documents) and populate tables (CSRs, summary documents); the Lead Editor may also be asked to write narratives for CSRs. This individual will also work on projects that reach beyond Medical Writing, to utilize his/her skillset in a broader team dynamic. The Lead Editor will be responsible for initiating new processes (both within and outside Medical Writing), and be responsible for the outcome/completion of those initiatives. The Lead Editor will be responsible for helping train more junior staff.
• Perform edit checks, including spelling/grammar, consistency, correct template use and section content for Clinical Study Protocols/Amendments, Clinical Study Reports, Investigator's Brochures, Clinical Summary Documents, Other documents, as needed
• Perform QC checks, including verifying consistency between hand-generated in-text tables and source tables, and between in-text numbers/ statements and source tables; ensuring consistency between sections; and verifying reference, table, figure, and listing citations on Clinical Study Protocols/Amendments, Clinical Study Reports, Investigator's Brochures, Clinical Summaries, and Other documents as needed.
• When needed, assist in writing parts of documents and narratives on priority level MW documents
• Lead cross-function development process teams to implement new initiatives
• Assist in training more junior staff
• Bachelor's degree (advanced degree preferred)
• Minimum of 6+ years of industry experience.
• Have edited clinical study reports, clinical protocols, clinical protocol amendments, IBs, IB updates, and clinical summaries for NDA/BLA/MAA, etc.
• Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.
• Have strong organizational, interpersonal and communication skills, and be able to develop and present varied and unique ideas
• Expected to have 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.