Patient Services and Regulatory Affairs

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Job Description:
ROLE OBJECTIVE

Answering routine correspondences on own initiative, preparing Excel spreadsheets/ PowerPoint presentations as required.

Undertake various projects as required by the PS Lead and RA Manager, including arranging Team Building events, booking meetings, finding out information, ordering cards/flowers, ordering stationery, archiving.

Liaison with IT helpdesk re hardware requirements or issues, ensuring timely resolution

Book external training courses/seminars as required.

Working hours are expected to be split 50 50 between PS and RA.

Key Accountabilities Of The Role
Provide administrative support to Patient Services Lead UK/IRE, including but not limited to

Schedule Meetings, both internally and externally

MRPSP Tracker – provide back up to Patient Services Team relating to changes to PSPs

TOV – work with homecare providers and Takeda TOV team to calculate annual TOV for nursing services

Manage UK Reports mailbox

Update Patient Services Teamsite ensuring relevant documents, links and information available and up to date

Manage PS Purchase Requisitions/Purchase Orders with all homecare providers

Calculate PO Value/Spend Projection

Timely reconciliation and approval of all monthly homecare invoices

Resolve errors and challenge spend as needed

Prompt response to homecare queries regarding invoices and payments

For FY21, number of PO's currently stand at 21 with 2 services classified as non-PO. 23 live services (excludes 2 new phlebotomy services and Oncology)

Liaise with Finance regarding Accruals for live POs

RA Support

Review of HPRA Product Information Schedules and artwork mock-ups as required by team members

Review and processing of parallel import notifications received from PLPI holders or Regulatory Authorities

Coordinating the monthly 'introduction to Regulatory Affairs' sessions

Preparation and submission of CPP applications/arrangement of notorisation and apostille by third party vendor

Completion of PSMF Annex H quarterly reviews (data verification exercise) and completion of necessary PRISM/GRACE updates

Document uploads to Electronic Document Management System(s)

Data entry in to regulatory information management databases

Maintenance of local product lists and coordination of periodic cross functional team reviews

Maintenance of local trackers (submissions/safety variations) and follow up with team members where gaps are identified

Scheduling and recording attendance at training sessions

Regulatory invoice coding and reconciliation of invoices vs MHRA and HPRA statements

Oversight of HPRA Fee request process

Storage of contracts and agreements on LINK/Ariba

Management of the LOC RA mailbox

LOC/Business Support

Ariba Key User – support business as needed. Part of key user community, respond/support other key users as needed. Knowledge of MDG, Ariba, Coupa

Active member of Takeda Administrator/Coordinator team - attend meetings and support/respond to questions raised by the team

Key Knowledge And/Or Experience Needed
Well organised and able to work under pressure.

Good verbal and written communication.

Enthusiasm and initiative.

Strong team focus.

Results focused.

Planning and Organising.

Attention to detail/Accuracy.

IT Literacy.

Experienced administrator with a sound understanding of systems.

Locations:
GBR - Paddington

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full time