The Fountain Group

They author and create content from source documentation.. Skills and Experience Must possess Chemistry, Manufacturing and Controls (CMC) experience and have some knowledge of CTD. A 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 a plus.. A working knowledge of cGMP's is desired.. Experience with CMC documentation pertinent to various dosage forms is a plus.

technical writer ii

<p>Pay: $35-$50/hrLocation: Bridgewater, NJJob Title: CMC Regulatory Technical Writer IIDuties Works closely with quality, manufacturing, Global Regulatory Affairs (GRA), and technical staff from global locations within industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers. Authors change controls, white papers, position papers, and technical reports. Contributes to various US, EU and rest of world (ROW) dossiers. They author and create content from source documentation. Recommend a table of contents for regulatory submissions, contribute to the regulatory strategy by helping to identify potential regulatory risk, and ensure dossier compliance. Skills and Experience Must possess Chemistry, Manufacturing and Controls (CMC) experience and have some knowledge of CTD. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have experience in the industry. Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus. A working knowledge of cGMP's is desired. Experience with CMC documentation pertinent to various dosage forms is a plus. Knowledge of US pharmaceutical regulations is essential. Exposure to non-US regulatory activities is desired, but not mandatory.</p>

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