Senior Technical Writer - Regulatory Affairs

The CMC Regulatory Technical II Writer 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. The CMC Regulatory Technical Writer also authors change controls, white papers, position papers, and technical reports.

The technical writer contributes to various US, EU and rest of world (ROW) dossiers. They author and create content from source documentation. He/She will recommend a table of contents for regulatory submissions, contribute to the regulatory strategy by helping to identify potential regulatory risk, and ensure dossier compliance. The technical writer helps address questions received from health authorities and author responses. He/She maintains an up to date knowledge of Common Technical Document (CTD) templates and document management systems.

Skills Experience:

The candidate 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 at least 5 years' 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.

This position requires the incumbent to be highly organized, self-motivated, and able to independently manage multiple priorities. The desired candidate will 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 within a multi-disciplinary team. Knowledge of US pharmaceutical regulations is essential. Exposure to non-US regulatory activities is desired, but not mandatory.

Education:

BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).

The hourly range for roles of this nature are $45 to $55/hour. Rates are heavily dependent on skills, experience, location and industry.