Temp-Associate Scientific Writer - Preclinical PK

Location
Tarrytown, New York
Posted
Nov 28, 2021
Ref
REGEA0026R1578
Required Education
Bachelors Degree
Position Type
Full time

Regeneron's Regulatory Liaison and Scientific Writing Group, located in Tarrytown, NY is seeking a Temporary full-time employee in the Preclinical Development and Protein Sciences group to independently author preclinical pharmacokinetic reports. In this exciting role you will provide assistance to Scientific and Sr. Scientific Writers in reviewing and performing a Quality Control (QC) check for various scientific reports and regulatory documents in support of all preclinical development programs, including INDs, pharmacokinetic and toxicokinetic reports, and other written documents in support of preclinical development programs, as determined by management.

A Typical Day in the Role Might Look Like:
  • Independently author preclinical pharmacokinetic reports
  • Provide editorial and QC review for IND written and tabulated summaries
  • Adhere to a report process flow and alert appropriate personnel if a process change or delay occurs
  • Communicates clearly and in a timely manner to a wide range of people
  • Takes direction well and assumes responsibility for getting the work done
  • Update and keep current the PCD Writing Group Sharepoint website
  • Abide by GLP, GCP, and all company SOP's pertinent to the position
  • Keeps current with software and regulatory guidances necessary for execution of job responsibilities

This Role Might Be For You If:
  • You have strong attention to detail, establishing priorities and scheduling
  • You are an excellent interpersonal and communication (verbal and written) skills
  • You have a demonstrated ability to work effectively in a flexible environment
  • You can work independently, take initiative and complete tasks to meet deadlines

This role requires a BS/MS with 0-5 years of experience. Candidates must be proficient in preparing accurate, written reports, with a basic background in the life sciences preferred. A strong attention to detail, ability establishing priorities and scheduling a plus. Must have excellent interpersonal and communication (verbal and written) skills. Computer proficiency (Word, Excel, Adobe and related software) and fluency in the English language is required. Basic understanding of the eCTD and the drug development process is a plus. GLP experience is a plus as is previous experience with biotechnology-derived compounds.