Large US hub for one of either Astellas/Takeda/Eisai (need mutual NDA in place for LifeSciHub to disclose).
Head of Non Clinical Writing and Submissions needing senior MW expertise for writing, QC, lifecycle management, and providing input, guidance and mentoring for less senior members of the team.
Hours and duration- to be determined. At present the need is to find the right expert, then will work from there. If full time hours are available, that might work very well. If less than full time hours are available, and it’s a good fit, sponsor will work around your availability.
Looking for extensive background in tox, pk, regulatory documents, summaries. Sponsor products cover a variety of modalities in several therapeutic areas. . Can write SOPs as well if needed. Work is both early development and post marketing, from briefing books to submissions.
8 years or more experience, preferably global experience. Need a deep understanding of the regulatory landscape and regulatory strategy- sufficient to be able to work closely with the regulatory strategists themselves. Need deep scientific understanding, PhD or equivalent demonstrated experience preferred, because “Scientists like to talk to other scientists.”
This is not a single project or submission, they are looking for someone who will be part of the team, function as an FTE from a sense of ownership and commitment standpoint, Looking for an ongoing relationship.
Technologies involved- PleaseReview, Documentum, homegrown eCTD templates, Veeva implementation pending.
Will add official sponsor “job description” shortly.