Editor, Regulatory Submissions

We are looking for a highly motivated Editor to add to our growing Scientific Writing team. An Editor performs document quality control (QC) functions in support of preclinical and clinical development programs, with a focus on multiple functional areas. Independently reviews documents such as study reports, submission-level documents, nonclinical contributions to Investigator Brochures and FDA Briefing Packages, manuscripts, and internal Scientific Writing documentation for spelling, grammar, consistency, accuracy, and adherence to company standards and styles. Trains on and performs drafting responsibilities for documents such as bioanalytical reports and summaries in support of INDs, CTAs, and/or BLAs, at discretion of manager. Makes regular contributions to document QC process discussions and periodic review of internal working practice documentation.

Please provide a cover letter as part of your application.

A typical day as an Editor may include:

• Document QC review assigned documents/deliverables for spelling/grammar, style, consistency, and verification against source documentation
• Train on editing techniques
• Ensure document QC review sign-off documentation is completed in a timely manner
• Train on management of group SharePoint site(s), which may include: fielding user requests and adding/updating metadata
• Contribute to document drafting at discretion/direction of manager
• Take direction well and assume responsibility for assigned tasks
• Keep current with software and regulatory guidance necessary for execution of job responsibilities
• Continually seek ways of improving processes pertinent to areas of responsibility
• Communicate clearly and in a timely manner to a wide range of people
• Identify areas of professional interest for future growth and work with manager to pursue them

This role may be for you if:

• Excellent interpersonal and communication (verbal and written) skills and proficient in use of all software required for document drafting
• Previous experience editing, drafting, or reviewing basic scientific/technical summary documents in support of preclinical and/or clinical drug development programs
• Advanced verbal and graphical data presentation skills
• Strong understanding of the eCTD and the drug development process
• Demonstrated ability to work effectively in a flexible environment
• Working knowledge of scientific information from multiple disciplines and ability to communicate this information with precision and clarity.
• Previous experience with formatting and reading and writing and/or editing technical documents
• Working knowledge of SharePoint administration and maintenance
• Computer proficiency (Microsoft Office Suite [Word, Excel], Adobe Acrobat, EndNote, and related software) and fluency in the English language is required

In order to be considered qualified for this role, a BS/MS degree in life science is required with 2+ years of editing experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$67,600.00 - $110,200.00