At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
The Position:
This position will work within the DSE PV Partner and Affiliate Management Team, as well as the Global Contracts Team, and will primarily be responsible for all activities related to contract and partner management. This includes the set-up of PV Agreements (PVAs) with partners/EU affiliates and Service Agreements with PV vendors, as well as maintaining oversight to ensure the exchange of safety information and that all required PV systems are implemented and operating appropriately among the parties. Additionally, the position works on enhancing PV regulatory intelligence processes and on operational PV regulatory intelligence activities (monitoring, tracking, and following up with subject matter experts (SMEs)). This function will also support the team with activities related to PV affiliate management (i.e. supporting affiliates with service provider contracts, aRMM-related activities, and SOP management) and PV Regulatory Intelligence (RI). This position will work with global teams (US, Japan) and will be involved in global discussions with strong knowledge of the EU PV system to enhance DS global standards on partner management. This position will report to the DSE PV Partner and Affiliate Management Lead and is expected to work independently while providing solutions/best practices and executing strategy to achieve proactive and continuous process enhancement.
Roles and Responsibilities:
- Implement and maintain PVAs/SDEAs with partners/EU affiliates/PV service providers, working with internal subject matter experts (SMEs) to ensure all PV requirements are covered in the contract and that contract terms are executed appropriately; perform timely review of existing PVAs/SDEAs and initiate revision where appropriate
- Maintain contract templates and ensure compliance in line with current global procedures
- Monitor and maintain the PVA/SDEA Tracking Tool (e.g. list of contracts, required commitments) to ensure all required activities defined in the contract are performed appropriately
- Coordinate and perform periodic communication with partners by leading negotiations and ensuring the contract is up-to-date and the process is operating well
- Collaborate in the provision of information required to update relevant sections of the PSMF
- Ensure appropriate implementation of new and/or updated PVAs/SDEAs by communicating to the appropriate SMEs and providing training
- Participate in PV-relevant vendor activity oversight and ensure correct PV safety wording is included in the contracts
- Provide affiliate support in the review and execution of local PVAs/SDEAs
- Participate in global working groups to improve contract management processes at global level and ensure alignment
PV Regulatory Intelligence Activities:
- Participate in process enhancements with regard to PV RI at DSE level to ensure that all legislation updates are detected and implemented on time and in the appropriate manner
- Provide expertise and work together with the DSE PV RI team, affiliates, and other subject matter experts to ensure that legislation updates are appropriately assessed and required changes implemented
EU Affiliate Management Activities:
- Support local personnel, cluster leads, and LSOs to ensure PV requirements and compliance in the respective countries, and that PV personnel are adequately trained
- Facilitate the local implementation of global processes related to partner management and PVRI
- Provide support to ensure consistency between global and local PV processes related to partner management and PVRI
Personal Skills and Professional Experience:
Education:
- Bachelor's degree at minimum required; Master's degree in Life Sciences, Pharmacy, or Medical Sciences preferred
Experience:
- 2–5 years of experience with an advanced degree; 5–8 years of experience with a bachelor's degree
- Strong knowledge of international, European, and PV laws and guidance
- Knowledge in contract/PV agreement management preferred
Competencies:
- Excellent written and verbal communication skills in English
- Highly reliable with accurate operating principles
- Analytical and systematic approach with strong problem-solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular at an intercultural level, with respect and appreciation of cultural diversity
- Proactive, autonomous, and reliable working style paired with the ability to work in international matrix teams
- Flexible and adaptable
