Scientific Writer

Location
Tarrytown, New York
Posted
Apr 26, 2018
Ref
12672BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

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 Scientific Writing and Regulatory Liaisons group at Regeneron provides support for the preparation of nonclinical, regulatory submission-supporting documents and the associated submission summaries covering the functional areas of pharmacology, pharmacokinetics, toxicology, and CMC (chemistry, manufacturing, and controls).

Full-time employee who independently drafts and manages review of documents for regulatory submission (IND and BLA) with a focus on nonclinical pharmacology (CTD Module 4 nonclinical pharmacology study reports and CTD module 2 nonclinical pharmacology summary sections) across various therapeutic target areas and contributes to drafting of related submission- supporting documents (IB, briefing package, DSURs, etc.) as needed.

Responsibilities
  • Working closely with the scientific Subject Matter Expert (SME), initiates drafting and independently prepares the first draft of assigned documents.
  • Critically reviews, interprets and conceptually organizes results from complex submission-supporting studies, deriving clear, concise and scientifically accurate key messages that support regulatory submission strategies.
  • Provides editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency, while maintaining adherence to proper format, regulatory requirements, and company guidelines/styles/drafting processes.
  • Initiates and manages multiple rounds of document review and ensuing revisions, interacting positively and professionally with all levels of reviewers from SME to senior management, effectively resolving conflicts and building consensus, as necessary.
  • Represents the Scientific Writing and Regulatory Liaisons group on multi-disciplinary drug development teams, proactively identifying and promptly communicating to management and fellow scientific writers any potential obstacles or issues threatening timely completion of assigned deliverables.
  • Simultaneously manages multiple overlapping projects at different stages and on separate development programs and contributes to overall process improvement.


Requirements
  • PhD degree in a life science with a minimum of 2 years of post-graduate experience. Experience in a non-research setting (such as editing, medical writing, program management, not-for–profit, pharmaceutical industry, or academic administration) a plus.
  • Proven track record of scientific writing and editorial experience, preferentially beyond submission of personal research papers, contribution to regulatory submissions a plus.
  • Ability to grasp complicated scientific and technical concepts, identify key messages, and clearly and concisely communicate relevant information tailored to the intended target audience.
  • Proficient with the use of word processing programs, scientific graphing and statistics software, electronic file sharing data bases, and electronic document review platforms; experience with use of SharePoint, PleaseReview; and GraphPad PRISM a plus,
  • Readily handles multiple projects across diverse therapeutic target areas with good attention to detail.
  • Comfortable working with incomplete information in a fast-paced, continually changing and rapidly evolving environment.
  • Fluency in written and spoken English is required.

About this Opportunity:
  • A cover letter must be included in the application for this position.

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.

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Requisition Number: 12672BR