Randstad US CMC Technical Writer in Cambridge, Massachusetts
CMC Technical Writer
salary:$59.67 - $70.20 per hour
date posted:Tuesday, October 12, 2021
industry:Professional, Scientific, and Technical Services
CMC Technical Writer
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!
location: Cambridge, Massachusetts
job type: Contract
salary: $59.67 - 70.20 per hour
work hours: 9 to 5
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
CMC Technical Writer will be responsible to partner with Regulatory Affairs CMC and the Technical & Quality SMEs to prepare biologic license applications.
Collaborate with Manufacturing Sciences, Technical Development, Quality, Analytical scientists and CMC functional area SMEs in Preparing Development Protocols, Reports and Technology Transfer Documents.
Support in writing portions of the CMC regulatory filings (Module 2 and Module 3 of a BLA).
Manage comments, support the operation of the review process and create updated draft for next phase review.
Critically review documents for consistency and quality.
Promote standardization of document process within organization
2-5+ years in the pharmaceutical industry with experience in biotech product development and manufacturing.
Experience in preparation of a CMC Sections of Regulatory Documents.
Thorough understanding of ICH and FDA guidelines, GMP and quality compliance requirements.
Demonstrated experience in collaborating with diverse cross functional groups.
Excellent verbal and writing communication skills.
Ability to handle multiple tasks independently and manage competing priorities.
Excellent collaboration skills with focus on timely delivery.
Strong organization and analytical skills.
skills: CMC, FDA, Regulatory Affairs Operations, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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