Associate Scientific Writer

Location
Tarrytown, NY, United States
Posted
Jul 14, 2019
Ref
16941BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Provides support for the Preclinical Development department. Drafts and manages reviews for pharmacokinetics, toxicokinetics, clinical bioanalysis, clinical pharmacology, and CMC reports. In addition, drafts pharmacokinetics, toxicology, and CMC documents in support of IND and BLA submissions. Provides quality control review for regulatory documents in support of INDs and BLAs, as well as other written documents in support of development projects, as determined by management.

Performs job responsibilities under the supervision of Scientific Writer or Sr. Scientific Writer. Works with all levels throughout the organization. Handles confidential information with discretion. Escalates complex issues to management, as applicable.

Job Responsibilities:

• Draft preclinical pharmacokinetics and toxicokinetics reports

• Draft CMC documents

• Draft pharmacokinetics and toxicology written and tabulated summaries

• Draft clinical bioanalytical reports (including research/experimental reports)

• Draft clinical pharmacology reports

• Provide editorial and document QC review for IND and BLA nonclinical written and tabulated summaries

• Manage group SharePoint site

• Manage multiple projects and timelines
Educational Requirements:

• Bachelor's degree in a life science (biology, chemistry, immunology, or biochemistry)

Experience

• 0-2 years supporting nonclinical/clinical development programs

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

• Basic understanding of the eCTD and the drug development process is a plus, as is GLP experience

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.