Senior Scientific Editor
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- United States
- Start date
- Sep 7, 2024
View more categoriesView less categories
- Discipline
- Quality, Quality Control, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
Independently reviews or supervises quality control (QC) or review of nonclinical regulatory submission documents, nonclinical contributions to Investigators Brochures, and Development Safety Update Reports 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. Manages periodic review of internal guidance documents and templates. Collaborates with writing staff across a broad range of therapeutic areas and drug modalities.
A typical day in this role may look like:
- Leads editorial support for Module 1 (Investigators Brochures and Development Safety Update Reports) and Module 2 (nonclinical overview and introduction, nonclinical pharmacology, pharmacokinetics, and toxicology written and tabulated summaries) documents
- Review assigned documents/deliverables for spelling/grammar, style, consistency, and verification against source documentation from multiple functional areas
- Create 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
- Manage and/or assist in training junior editing staff
- Communicate clearly and in a timely manner to a wide range of people
JOB REQUIREMENTS:
Education
- Minimum of a BS degree in a life science
Experience
- 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)
- Advanced verbal and graphical data presentation skills
- Strong understanding of the eCTD and the drug development process
- Demonstrated understanding of nonclinical subject matter supporting drug development (ie, pharmacokinetics, pharmacology, and toxicology) and ability to communicate this information with precision and clarity
- Previous experience in managing people preferred
- Computer proficiency (Microsoft Office Suite [Word, Excel], Adobe Acrobat, and related software) and fluency 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)
$81,000.00 - $132,200.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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