Intelligence Manager in Pharmaceuticals
4 days ago
TN Ireland is seeking a highly skilled and proactive Intelligence Manager in Pharmaceuticals to join our team.
The successful candidate will be responsible for supporting the dissemination of relevant regulatory intelligence information to stakeholders, while also preparing responses to cross-functional requests and initiatives from assigned departments or functions within the organization's GxP framework.
This role requires a solid understanding of the drug development and commercialization process globally, with a focus on one to a few functional areas. The ideal candidate will have experience in managing intelligence query requests from internal stakeholders and facilitating regulatory intelligence review meetings and/or learning series sessions.
The key responsibilities of this role include:
- Support the dissemination of relevant regulatory intelligence information to stakeholders.
- Prepare responses to cross-functional requests and initiatives from assigned departments or functions within the organization's GxP framework.
- Manage intelligence query requests from internal stakeholders.
- Facilitate regulatory intelligence review meetings and/or learning series sessions.
- Regularly review and assess incoming regulatory information in the global regulatory intelligence database and distribute relevant updates to reviewers from appropriate functions within the company.
Required qualifications and skills:
- Minimum Bachelor's Degree in a life science or related field.
- Minimum of 5 years' experience in the biotech/pharmaceutical industry or health authority.
- Solid understanding of the drug development and commercialization process globally.
- Experience in preparing responses to cross-functional requests and initiatives.
- Proficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDx.
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