MS/PhD Scientific Writer in PreClinical Development
- Organization:
- Regeneron
Regeneron Pharmaceuticals is seeking a full-time Pre Clinical Scientific Writer in the Preclinical Regulatory Liaison Group to independently author various reports and regulatory documents in support of all preclinical development programs, including INDs, Investigator Brochures, FDA Briefing Packages, sample analysis reports, and other written documents, as determined by management.
The ideal candidate for the position will have experience in:
- Independently authoring various preclinical summaries and Nonclinical Overviews
- Experience with IND and BLA submissions for biotechnology-derived drugs
- Working knowledge of GLP and ELISAs
This position allows the individual to work up to 2 days a week from home.
Desired Skills & Experience
- MS/PhD degree
- At least 2-5 years of PreClinical Writing and GLP industry experience
- Most recent experience as a PreClinical Scientific writing
- Experience working in various Therapeutic Areas
- Ability to independently author the associated sections of regulatory submissions
- Ability to supporting study reports (IND, BLA, IBs) is a must
- Computer proficiency (Word, Excel, Adobe and related software)
- Fluency in the English language is required
The hiring level is commensurate with experience.
Company Description
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits.EOE/M/F/D/V
Disclaimer: Effective immediately, Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex.