Scientific Writer

Drafts and manages reviews of submission documents with a focus on nonclinical pharmacology across various indications and TFAs. Participate in relevant cross-functional drug development meetings. Applies critical evaluation and scientific analysis skills to help develop conclusions and key messaging from data in collaboration with the subject matter experts, ensuring that drafted content support the regulatory and clinical submission strategy. Independently prepares eCTD written and tabulated summaries for nonclinical pharmacology and contributes to cross-functional documents with content from multiple functional areas (nonclinical pharmacology, preclinical pharmacokinetics, or toxicology). Prepares, updates, and maintains document templates and internal guidance documents.

A day in the life may look like:

• Independently author nonclinical/quality/clinical documents for submission to health authorities worldwide

• Prepare and/or review manuscripts for publication

• Participate in the creation, revision, and maintenance of document templates or shells

• Manage multiple projects and associated timelines

• Supervise professionals or exempt employees, as applicable

• Provide mentorship/training to developing team members

• Document and implement consensus at meetings to determine data interpretation and key findings/messages

• Abide by and keep current with GxP and regulatory guidelines and all company SOPs or WPs pertinent to the position

• As requested, participate in the creation and/or review of SOPs and working practices pertinent to areas of responsibility

This may be the right role for you if you have:

• Good knowledge of drug development and regulatory submission (eCTD) guidelines and processes

• Previous experience working in a cross-functional drug development team preferred

• Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required

In order to be considered for this role, we are looking for candidates who have:

• 3 to 5 years of experience in relevant professional settings, Bachelor’s degree or MS/PhD/PharmD in a life science, advanced degree preferred

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)

$106,200.00 - $173,200.00