Senior Scientific Writer

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
Full-time employee in the Scientific Writing and Regulatory Liaisons group to write and manage review and revision of eCTD Module 2.4 Non-clinical Overview and other nonclinical modules (as required) in support of IND/BLA submissions. Incumbent will draw on an eclectic background in drug development science to critically review, edit and manage revisions of draft eCTD Modules 2.6.2/3 Pharmacology Written/Tabulated Summary, 2.6.4/5 Pharmacokinetic Written Summary, and 2.6.6/7 Toxicology Written/Tabulated Summary prepared by the Scientific Writers, initiating and managing corrective action where necessary to ensure clear, concise and fully-compliant regulatory submissions. The scope of this position additionally includes the writing and review of scientific research reports, journal articles, protocols, and global regulatory submission documents using regulatory-compliant document formatting and quality standards.

Responsibilities

• With minimal supervision, writes eCTD Module 2.4 Nonclinical Overview by organizing key messages from the supporting eCTD Module 2 nonclinical sections into a scientifically sound, integrated summary leading to a logical and concise overview and conclusion that is fully aligned with regulatory submission strategy and unambiguously supports FIH studies.
• With minimal supervision, writes nonclinical eCTD Modules 2.6.2/3, 2.6.4/5, or 2.6.6/7 written/tabulated summaries as assigned.
• Initiates and manages document review cycles and all revisions, interacting positively and professionally with contributing SMEs and all levels of reviewers, effectively resolving conflicts and building consensus at every step in the revision process, while ensuring accuracy, consistency and timely delivery of a high-quality submission.
• Provides guidance and mentorship to the Scientific Writer by critically reviewing and editing the draft eCTD Module 2 nonclinical summary sections (Pharmacology, Pharmacokinetic, Toxicology), providing advice on writing style to ensure clarity, readability, quality and consistency of messaging.
• Provides guidance to the Scientific Writer during document review and revision.
• 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.
• Critically reviews submission-supporting research reports, identifying existing gaps and initiating and managing necessary revisions to ensure conformity with regulatory requirements and overall submission strategy. Writes and reviews research reports, manuscripts and other documents to ensure appropriate evaluation, interpretation and presentation of data, methodology, and alignment with business and regulatory objectives.
• Manages relationships with both internal and external (partner company) reviewers and provides expert input during development of team deliverables.
• Routinely manages multiple projects simultaneously in an efficient and timely manner while providing clear, concise status updates to Supervisor and appropriate internal partners.
• Critically reviews, interprets and conceptually organizes results from complex submission-supporting study reports, deriving clear, concise and scientifically accurate key messages that support regulatory submission strategies.
• Represents the Scientific Writing group on multi-disciplinary drug development teams, actively contributing to the development of key scientific messages that support regulatory strategy, and promptly communicating to Supervisor and internal collaborators any potential obstacles or issues jeopardizing timely completion of deliverables.
• May assign work to, and oversee the activities of, the Scientific and Associated Scientific Writers.
• Abides by GLP, GCP, and all company SOP's pertinent to the position.
• Participate in various task force activities and project meetings related to area(s) of responsibility.
• Update and keep current the PCD Writing Group Sharepoint website.
• Keeps current with software and regulatory guidances necessary for execution of job responsibilities.
• Keeps abreast of the science of biotechnology-derived drugs and their development.
• Takes direction well and assumes responsibility for getting the work done
• Maintains a positive attitude and readily adapts to changes necessary to grow the business
• Anticipates future needs and develops appropriate strategies to provide new deliverables.
• Continually seeks ways to improve drafting efficiency and turnaround time for the SAR.

Requirements

• PhD in a life science with a minimum of 8 yrs. (BS/MS with minimum of 10 yrs.) experience in pharmaceutical drug development, of which a minimum of 5 years was spent as the lead author of IND/BLA nonclinical eCTD Module 2 summary sections for biotechnology-derived drugs. Awareness of compliance issues and guidelines germane to IND and BLA submissions required.
• Eclectic and multidisciplinary background in the pharmaceutical sciences, with a thorough understanding of the drug development process.
• Ability to grasp complicated technical concepts outside of immediate area of expertise and apply this understanding to the drafting of scientifically sound and fully compliant regulatory submissions.
• Exceptional interpersonal skills for dealing positively and professionally with senior SMEs and reviewers at all levels within the company.
• Exceptional written communication skills to prepare and edit regulatory submissions, research reports, manuscripts, and other regulatory or research communications documents.
• Proficiency as the lead author of eCTD Module 2 summaries is required; experience in drafting related submission-supporting scientific/technical documents is a plus.
• Proficient in the use of electronic data bases for document drafting (e.g., SharePoint, Documentum, etc.) and electronic document review software (e.g., Please Review).
• Prepares all documents with scrupulous and unfaltering attention to detail, performing all necessary crosschecks to ensure accuracy of reported data.
• Ability to grasp complicated technical subjects, synthesize diverse lines of evidence and apply these abilities to scientific writing.
• Comfortable working with incomplete information in a fast-paced, continually changing and rapidly evolving environment.
• Works effectively on multi-disciplinary teams, using strong organizational, communication, and interpersonal skills to facilitate discussions and decision-making.
• Communicates clearly, effectively and in a timely manner to many levels within the company.
• Flexible, with a positive attitude and a demonstrated ability to manage multiple competing priorities under time constraints, while ensuring consistent, high quality of all deliverables.
• Approaches assignments with an entrepreneurial spirit, regularly seeking opportunities to contribute added value; proactively contributes to continuous improvement in the Scientific Writing group.
• Able to work effectively in a flexible environment, including distance-based working relationships.
• Fluency in the English language is required.

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.