This position is accountable for supporting the day-to-day compliance program for employees in Takeda’s Chief Medical & Scientific Officer (CMSO) organization based in the US. Along with R&D Compliance colleagues, he/she is responsible for embedding the elements of an effective compliance program throughout the US R&D organization, including Takeda Development Centers-US, and US-based employees in Pharmaceutical Development Division (PDD), Global Medical Affairs (GMA), Oncology Business Unit, New Frontier Science, and Therapeutic Area Units (TAU).
ACCOUNTABILITIES:
Responsible for providing strategic input into Global Compliance Policies and SOPs that affect US-based CMSO employees.
Anticipates changing industry regulatory climate and assists in proactively aligning function goals and processes with current regulatory expectations. Interacts regularly with industry peers, Takeda Legal and Regulatory personnel and vendors to help shape direction of the R&D compliance program.
Responsible for providing guidance to all US-based CMSO personnel who contact the Global Compliance Hotline.
Provides compliance support for alliance partnerships for R&D organizations from a compliance perspective. These partnerships include co-licensing and joint venture agreements. Responsibility for working in conjunction with his/her counterparts in these organizations to ensure compliance with state and federal health care program requirements.
Responsible for leading and understanding evolving risks throughout the pharmaceutical pipeline cycle and ensuring adequate controls in place to mitigate those risks.
Actively participate in and potentially manage day-to-day compliance monitoring initiatives to ensure compliance with Takeda policies involving advisory boards, Investigator Initiated Sponsored Research (IISR), Takeda-conducted clinical trials, Investigator meetings, Sponsorships, Consulting and other fee for service arrangements, and other business activities that involve HCPs within the CMSO organization.
Responsible for assisting in the coordination of R&D Compliance Committee meetings.
Job
Education, Experience And Skills
Required
Bachelor’s Degree
10 years of experience in healthcare industry, a portion of which involves R&D
Excellent communication skills
Proficient in Microsoft Office products
Solid understanding of state and federal health care laws/regulations
Demonstrated project and program management skills. Experience in leading cross-functional projects and initiatives.
Strong customer relationship skills and ability to interact with all levels of management, vendors and partners.
Proactive, self-motivated, and able to work well in dynamic environment while consistently exercising good judgment.
Able to work and deliver on deadlines while managing multiple projects and priorities effectively
Preferred
Pharmaceutical compliance experience with 5 years in an R&D compliance related role
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