Offer summary

Qualifications:

Minimum of a BS degree in life sciences., At least 4 years of experience in editing regulatory submission documents., Excellent verbal and written communication skills., Proficient in document management platforms and Microsoft Office Suite..

Key responsibilities:

Review and supervise quality control of regulatory submission documents.

Collaborate with writing staff across various therapeutic areas.

Lead training initiatives for junior editing staff.

Ensure adherence to established QC review processes.

Job description

The Senior Editor independently reviews or supervises quality control (QC) or review of nonclinical regulatory submission documents for spelling, grammar, consistency, accuracy, and adherence to company standards and styles. Maintains list(s) of QC comments/style questions and their resolutions within the group to ensure consistency within and/or between documents from multiple functional areas. Runs periodic review of internal guidance documents and templates. Collaborates with writing staff across a broad range of therapeutic areas and drug modalities.

As a Senior Editor, a typical day may include:

Editorial support for one or more of the following areas: Module 1 (Investigator’s Brochures and Development Safety Update Reports), Module 2 (nonclinical overview and introduction and nonclinical summaries), Module 3 (quality documents), and Module 4 (nonclinical study reports)
Review assigned documents/deliverables for spelling/grammar, style, consistency, and verification against source documentation from multiple functional areas
Build and maintain QC checklists for use throughout the group
Ensure editing staff adheres to the established QC review process
Lead initiatives for editing process improvements and software implementation
Lead and/or assist in training junior editing staff
Communicate clearly and in a timely manner to a wide range of people

To be considered for this role, you must have:

Minimum of a BS degree in life sciences

Minimum of 4 years of experience editing, formatting, drafting, or reviewing regulatory submission documents
Excellent interpersonal and communication (verbal and written) skills
Proficient in use of all software required for document drafting as well as document management platforms (eg, SharePoint and Veeva Vault RIM)
Sophisticated verbal and graphical data presentation skills
Strong understanding of the eCTD and the drug development process
Proven understanding of bioanalytical sciences and nonclinical subject matter supporting drug development (ie, pharmacokinetics, pharmacology, and toxicology) and ability to communicate this information with precision and transparency
Computer proficiency (Microsoft Office Suite [Word, Excel], Adobe Acrobat, EndNote, and related software) and proficiency in the English language is required

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)

$70,700.00 - $115,100.00

Required profile