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Job Description
Please be aware that you might not receive a response to your application to this role. Indeed, we see some future needs in the Patient Access area at Takeda.
The team has good chances of growing in the near future and if you think the area of Patient Access and the company Takeda could be of interest for you sometimes later, I encourage you to send us your CV by applying to this role directly.
Job Description
Job Overview:
Manage operational implementation and ongoing execution of Patient Access Programs(s)
Serve as the lead for program(s) Individual Patient Request (IPR), Named Patient Program (NPP), Post Trial Access (PTA) interfacing with internal stakeholders in Global, Regional, and Local offices as well as external vendors to ensure efficient and compliant delivery of assigned GMA Patient Access programs, and quickly resolve issues when raised.
Manage program level internal training, tracking, and reporting supporting patient access initiatives.
Manage/provide support to other Patient Access initiatives/Program upon assignment
Key Responsibilities:
Responsible of project plans against timelines and budget
Responsible of procurement activities for vendor selection, contracting and support in reviewing SOW
Responsible of designing supporting processes and/or procedures to support Patient Access Programs(s)
Responsible of setting up and/or facilitating team meeting as required, capture minutes and disseminate those, follow up on actions
Support in creating communication strategy to ensure awareness of the initiatives and capture appropriate feedback from functions and/or regions and or LOCs
Responsible for executing Patient Access Programs across TAKEDA portfolio in relation to Patient Access mechanisms
Manage relationships with key external partners and vendors on behalf of Patient Access. Track and report on achievement of partnership milestones
Drive the execution of Patient Access activities to ensure they meet overall HEPA objectives
Liaise with Patient Access leadership management, partners to ensure targets and standards are met
Provide operational management of assigned program for Patient Access programs (program implementation, maintenance, and closure) escalating issues as required.
Operational budget oversight for overall Patient Access Program(s)
Monitor operational development progress against established timelines, budget and deliverables, escalating issues as needed and provide regular and ad hoc program reports to internal stakeholders, including updates
Management of the day-to-day vendor operational relationship to ensure successful execution and adherence to service level agreements
Collaborate with internal stakeholders for program(s), including but not limited to Patient Access, Global Medical, Legal, Data Protection, Clinical Supply/Supply Chain, Clinical Operations, Regulatory, Quality, Pharmacovigilance, Regions and applicable Business Units linked to Patient Access programs, ensuring alignment with stakeholder needs.
Deliver ad hoc training sessions to educate new and current colleagues in Patient Access programs, internal & external stakeholders. Creating materials where required/requested
Support Head, GM Patient Access with internal awareness, education and training of GM Patient Access policies and SOPs and lead training on related digital initiative(s)
Patient Access knowledge/experience and understanding of global research and development and the interface with other organizations, functions and business units, ability to liaise with colleagues in different functions across the business
Support the operational execution of in alignment of Patient Access strategy. Serve as the lead for interfacing with internal stakeholders in Global, Regions and vendors to ensure efficient and compliant delivery of assigned deliverables, and quickly resolve issues when raised.
Ability to collaborate across regions and functions with minimal direct authority, strong problem-solving skills required)
Operational management of assigned programs with escalation where required
Collaborate with internal stakeholders for assigned programs, including but not limited to Patient Access, Global Medical, Legal, Data Protection, Clinical Supply/Supply Chain, Clinical Operations, Regulatory, Quality, Pharmacovigilance Regions and applicable Business Units linked to Patient Access programs, ensuring alignment with stakeholder needs
Knowledge of and experience in patient care and procurement of medicines is a key desirable knowledge set. Ability to innovate and create solutions to complex problems is critical.
Works on assigned Global Patient Access Program(s) development to serve the Takeda portfolio, Liaison with internal stakeholders and external vendors. Works across the globe with many countries regulatory requirements and cultures
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Education, Experience & Skills:
Minimum Bachelor\\xe2\\x80\\x99s degree required ideally Healthcare Professional qualifications (pharmacist, nurse, etc.) or an advanced degree (MS/MBA/MPH/PhD) in a health sciences related field desirable
6 years of relevant professional experience in the biopharmaceutical industry OR CRO required in a multi-disciplinary, global environment (R&D, medical or commercial organization preferred)
2+ years of effective project management, clinical operations and/or direct involvement with Patient Access/Early Access/ Managed Access Programs
Good understanding of global regulatory and compliance requirements for patient access, clinical research, including but not limited to good knowledge of medical terminology, RWE, GDPR, and ICH GCP.
Past experiences in managing vendors and/or agency
Past experience in managing clinical projects, included ability to keep track of timelines, follow up on deliverables and outstanding, budget and timely address or escalate bottlenecks
Knowledge of global research and development and the interface with other organizations, functions and business units
Experience working with clinical supply/supply chain, vendors and external organizations (including corporations, associations, non-governmental organizations, and academic institutions) relevant to the patient access field
Experience working within a complex, global organization and demonstrated ability to work across functions and regions at all levels without minimal direct authority
Experience leading cross-functional initiatives.
Self-driven and clear track record of results delivery
Strong ability to multi-task and cope with changing priorities and timelines
Strong problem-solving skills and resilience
Strong written and oral communication and presentation skills