Nominated Signatory/ Medical Excellence ManagerApply NowEmail Me Job ID R0023103 Date posted 09/28/2020 Location: Stockholm, Sweden
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Nominated Signatory/ Medical Excellence Manager in Sweden.
At Takeda, we are transforming the pharmaceutical industry through our R&D - driven market leadership and being a values-led company. To do this, we empower our people to realize their potentialthroughlife-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and striveforexcellence in everything we do. We foster an inclusive,collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a BrighterFuture topeople around the world.
The Nominated Signatory reports directly to the Medical Director and is responsible for all promotional and non-promotional materials. The Nominated Signatory is responsible for ensuring that the company is following all local and Takeda-related laws and regulations regarding the development, review, approval and dissemination of promotional and non-promotional materials linked to Takeda products or disease areas. This includes:
- training and guidance of Takeda personnel,
- oversight of systems and processes
- drafting and developing SOPs and work instructions.
- Approval of activities - supports Medical Director and medical team in execution of activities linked to HCP, including follow up of training. Screens activities related to HCP before approval by medical director to ensure compliance with local and global rules and regulations
- Supports the medical team in project execution and evidence generation, including:
- SOP gap assessment
- Writing and reviewing SOPs related to medical GxP activities
- Project management
- Ad hoc support for Medical department projects
- PharmD or relevant Master's Degree in life science
- LER training
- Experience working as Nominated Signatory, or other relevant compliance experience from pharma
Empowering Our People toShine
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SWE - Stockholm