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.
Full-time employee in the Preclinical Development and Protein Sciences group to independently author preclinical pharmacokinetic reports. 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.
â€¢ Independently author preclinical pharmacokinetic reports
â€¢ Provide editorial and QC review for IND written and tabulated summaries
â€¢ Adhere to a report process flow and alert appropriate personnel if a process change or delay occurs
â€¢ Communicates clearly and in a timely manner to a wide range of people
â€¢ Takes direction well and assumes responsibility for getting the work done
â€¢ Update and keep current the PCD Writing Group Sharepoint website
â€¢ Abide by GLP, GCP, and all company SOP's pertinent to the position
â€¢ Keeps current with software and regulatory guidances necessary for execution of job responsibilities
â€¢ BS/MS degree in life sciences with 0-5 years of relevant experience
â€¢ Proficient in preparing accurate, written reports
â€¢ Strong attention to detail, establishing priorities and scheduling
â€¢ Excellent interpersonal and communication (verbal and written) skills
â€¢ Demonstrate ability to work effectively in a flexible environment
â€¢ Ability to work independently, take initiative and complete tasks to meet deadlines
â€¢ Computer proficiency (Word, Excel, Adobe and related software) and fluency in the English language is required
â€¢ Basic understanding of the eCTD and the drug development process is a plus
â€¢ GLP experience is a plus as is previous experience with biotechnology-derived compounds
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.
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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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