Regeneron is seeking a highly motivated Scientific Writer to participate in drafting and managing reviews of submission documents for nonclinical pharmacology spanning across many therapeutic areas. In this exciting role you will work alongside scientists to interpret data and develop key messaging, culminating in preparation of nonclinical pharmacology content for submission to health authorities worldwide.
A typical day in the role might include:
Working with scientists, Research Program Management, and Regulatory Affairs to interpret and develop the data package for a drug candidate
Independently authoring and managing internal reviews of nonclinical study reports, eCTD summary documents, and Investigator’s Brochures
Driving documents through comment reconciliation by creating consensus among key stakeholders up through Senior Management
Simultaneously advancing multiple projects while adhering to submission target timelines
Participating in process improvement by creating or revising internal guidance documents and templates, or by implementing new technology solutions
Training and supporting consultants or junior writers working within the Scientific Writing group
This role may be for you if you:
Have a passion for science and teamwork
Have experience with the eCTD and the drug development process
Have strong attention to detail, time-management skills, and scientific rigor
Have computer proficiency (Word, Excel, Adobe, GraphPad Prism)
Are fluent in the English language
This role requires a BS or MS with 6+ years, or PhD in a Life Sciences-related field with 2+ years of relevant experience (eg, scientific/regulatory writing or pharmaceutical industry).
Submitting a cover letter is strongly encouraged.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
