Scientific Writer/ Sr. Scientific Writer

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Role
Editorial
Industry
Biotechnology
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary:
Full-time employee to write eCTD Module 2 nonclinical summary sections for IND and BLA submissions, including supporting documentation as required, and initiate and manage document reviews and all ensuing revisions. Incumbent will be expected to contribute to and, where appropriate, lead the development of operating guidelines and templates and continued process improvement in the Scientific Writing group.

Responsibilities:
Working closely with the Subject Matter Expert (SME), initiates drafting and independently prepares the first draft of assigned eCTD Module 2 nonclinical written and tabulated summaries (Pharmacology, Toxicology, or Pharmacokinetics), providing advice on scientific writing, as well as standardized language for submissions and editorial support. May be required to contribute to drafting of related submission- supporting documentation (IB sections, research reports, briefing package sections, DSURs, responses to regulatory agencies, etc.)
  • Provides editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy and consistency, while maintaing 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, effectively resolving conflicts and building consensus at every step in the revision process, while ensuring accuracy, consistency and quality of the final document.
  • 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, proactively identifying and promptly communicating to management any potential obstacles or issues impeding timely completion of deliverables.
  • May assign work to, and oversee the activities of, the Associate Scientific Writers.
  • 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.
  • Abides by GLP, GCP, and all company SOP's pertinent to the position.
Requirements:
Proficiency as the lead author of eCTD Module 2 summaries is required; experience in drafting related submission-supporting scientific/technical documents is a plus.
  • Exceptional interpersonal skills for dealing positively and professionally with senior SMEs and reviewers at all levels within the company.
  • Proficient in the use of electronic data bases for document drafting (e.g., SharePoint, Documentum, etc.) and electronic document review software (e.g., PleaseReview).
  • 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.
  • Thorough understanding of the drug development process.
  • 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 faciltate 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.
  • Awareness of compliance issues and guidelines germane to IND and BLA submissions.
Minimum of a BS degree (PhD preferred) in a life science with a minimum of 3 yrs. hands-on experience in pharmaceutical drug development as the lead author of IND/BLA nonclinical eCTD Module 2 summary sections for biotechnology-derived drugs. Ideal candidate is a Subject Matter Expert in Pharmacokinetics (PK) and has 8-10 years of post-PhD work experience, along with experience leading a team of writers.

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 Regenerons 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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