We're looking for a Technical Writer II, working in the Pharmaceuticals & Medical Products industry in Bridgewater Township, New Jersey, United States.
Works closely with quality, manufacturing, regulatory, and technical staff from global locations within client's industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 CMC regulatory submissions for development and post-approval dossiers in eCTD format.
Authors change controls, following company's change control procedures.
Contributes to various US, EU and rest of world (ROW) registrations
Authors and creates dossier content from source documentation for registrations, and provides writing support for technical reports.
Recommends table of contents for regulatory submissions.
Contributes to regulatory strategy for successful product registration.
The pay we are offering is 71 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
BS/BA or MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
7 years experience in the pharmaceutical industry, which includes no less than 4 years of experience with CMC regulatory related activities.
Must possess substantial Chemistry, Manufacturing and Controls (CMC) and Common Technical Document (CTD) authoring experience.
Background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is mandatory.
Working knowledge of cGMP’s is desired.
Experience with CMC documentation pertinent to various dosage forms is needed.
Highly organized, self-motivated, and able to independently manage multiple priorities.
Have the capacity to be productive with very little supervision, and should enjoy writing.
Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact with a multi-disciplinary team.
Knowledge of US pharmaceutical regulations is essential.
Exposure to non-US regulatory activities is desired, but not mandatory.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.