Senior Business Systems Lead — Trial Delivery & Roadmap
POL - 6999 Takeda SCE
Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.
Job summary
Takeda is seeking a seasoned Business System Owner for trial delivery systems in Poland (Lodz/Warsaw). You will partner with Data, Digital & Technology to prioritize roadmaps and ensure delivery in line with GxP and 21 CFR Part 11 requirements, supporting the SDLC and regulatory inspections.
The role requires a BS/BA with 5-7 years in life sciences or drug development, experience with Veeva EDC/CTMS, budget planning, and strong cross-functional collaboration and communication.
Qualifications
- BS/BA required with 5-7 years of relevant experience in the life sciences or drug development.
- Experience with Veeva EDC or Veeva Clinical eTMF/CTMS highly preferred.
- Experience with GxP validation and 21 CFR Part 11 requirements is important.
- Experience with budget management, forecasting and cross-functional collaboration.
- Strong verbal and written communication and influencing across levels.
Responsibilities
- Partner with Data, Digital & Technology to drive roadmap delivery for trial systems.
- Serve as Business System Owner for trial delivery systems and support the SDLC.
- Develop and maintain cross-functional stakeholder relationships across R&D and Enterprise.
- Contribute to inspection readiness and represent system expertise for inspections.
- Support budget planning and investment oversight for trial delivery systems.
Skills
Education
Job description
Takeda is seeking a seasoned Business System Owner for trial delivery systems in Poland (Lodz/Warsaw). You will partner with Data, Digital & Technology to prioritize roadmaps and ensure delivery in line with GxP and 21 CFR Part 11 requirements, supporting the SDLC and regulatory inspections.
The role requires a BS/BA with 5-7 years in life sciences or drug development, experience with Veeva EDC/CTMS, budget planning, and strong cross-functional collaboration and communication.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
