The CMC Regulatory Technical Writer works closely with quality, manufacturing, global regulatory affairs, and technical staff from global locations within the CLIENT’S 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 Technical Writer contributes to various US, EU and rest of world (ROW) dossiers.
- They author and create content from source documentation.
- 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.
- Maintains up to date knowledge of the CLIENT’S Common Technical Document (CTD) templates and document management systems.
- Will author change controls, white papers, position papers, and technical reports.
- BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
- Must have Chemistry, Manufacturing and Controls (CMC) experience and have some knowledge of CTD.
- Must have a background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
- Must have minimum of 5 years' experience in the industry.
- Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus.
- Working knowledge of cGMP’s is desired.
- Experience with CMC documentation pertinent to various dosage forms is a plus.
- Must be highly organized, self-motivated, and able to independently manage multiple priorities.
- Must have the capacity to be productive with very little supervision and should enjoy writing.
- Excellent interpersonal communication skills are required
- 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.