Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a Director/ Associate Director, Non-Clinical Writing to provide the global non-clinical writing group strategic direction, leadership and scientific writing content expertise for multiple compounds and/or projects.
- Responsible for developing, implementing and assuring execution of strategic global non-clinical writing plans.
- Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated non-clinical regulatory documents (US and ex-US).
- Coordinates the review, approval, and other appropriate functions involved in the production of non-clinical regulatory documents.
- Oversees compliance with relevant internal and external standards, and maintains a functional group that meets or exceeds industry standards.
- Works with project teams and functions across global sites in coordination of delivery timelines for non-clinical documents.
- Assesses resource needs as timelines progress, and communicates those needs to senior management.
- Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
- Arranges and conducts review meetings with team members.
- Resolves document content issues and questions arising during the writing process.
- Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical and non-clinical regulatory document preparation and submissions.
- Recommends, leads, and implements tactical process improvements.
- Familiarity with Standard Exchange for Non-clinical Data (SEND) is desirable.
- Knowledge and expertise with Common Technical Document content templates.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.