Biologics CMC Writer in Talleyville, DE at Eliassen Group

Date Posted: 8/4/2022

Job Snapshot

Job Description

**100% Remote**

Our global biopharma client needs a Biologics CMC (Chemistry, Manufacturing, and Controls) Writer to support quality section authoring of a BLA submission and help with other technical documents.

Contract Length: 6 months with opportunity to extend an additional 6 months

We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Responsibilities of the Biologics CMC Writer:
  • Draft and edit CMC drug product "S" sections of regulatory documents for submission to regulatory agencies worldwide
  • Work with SMEs to write and edit SOPs, specifications, batch documentation, and related
  • Work closely with technical operations team to ensure alignment and established priorities 
  • Collaborate with QA and regulatory affairs teams to ensure successful completion of regulatory submissions
  • Ensure a uniform style and language for regulatory compliance
Requirements of the Biologics CMC Writer:
  • Bachelor's degree in Biological Sciences, Regulatory Affairs, or related
  • 3+ years of experience writing CMC sections of regulatory filings
  • Experience authoring drug product "S" sections of BLA submissions
  • Demonstrated record on regulatory submissions of biological products
  • Demonstrated competency in clear and concise technical documentation
  • Strong cross-functional communication and collaboration skills
  • Experience with monoclonal antibody products a plus
Job ID: 369534

About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!