Head of Medical Affairs Belgium

il y a 2 jours

Brussels, Belgique Takeda Pharmaceutical Temps plein

Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**

**ROLE OBJECTIVE**
- Provide strategic leadership of Medical Affairs and RA/QA personnel, through exceptional focus on patients’ needs and safety, to support better health and a brighter future for the patients we serve
- Develop, manage and lead the Medical Affairs Managers and MSL Teams to support Medical Affairs activities for the broader portfolio
- Represent local medical and RA/QA functions in a professional and competent manner towards internal and external stakeholders; ensure alignment, collaboration and proactive sharing of relevant information across all departments
- Ensure compliance of LOC / MCO to the code of conduct, corporate philosophy, relevant laws and regulations as well as SOPs and policies
- Leads Medical Affairs and RA/QA teams in alignment with the overall company vision and direction for the portfolio at LOC level and across EUCAN

**ACCOUNTABILITIES**

**Leadership**
- Provide input into the overall strategic roadmap of the LOC incl. building of required capabilities for the future
- Ensure medical plans are aligned cross-functionally and aligned with the company’s strategy as well as delivered on time and on budget
- Leverage strong leadership to develop and attract highly qualified employees to the company and develop and motivate our people to achieve ambitious objectives
- Support on-boarding, training and knowledge transfer within the medical and QA/RA department providing an upskilling on areas of improvement as agreed within the leadership team
- Ambassador for Corporate Philosophy and Takeda-ism
- Lead local processes to align and onboard medical resources based on our evolving needs of our dynamic portfolio

**Medical/Scientific Affairs**
- Responsible for adherence to Global / EUCAN Compliance Standards for the Non-Commercial (Scientific) processes
- Guarantee scientific accuracy and adherence to ethical and industry standards regarding medical information, medical staff and sales force training, promotion of products marketed in accordance with the local Drug Law and Takeda’s standards / SOPs
- Oversee development of local tactical medical plans in line with the BU strategy and execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
- Liaise with other Department Heads (BU, PVA) to ensure common understanding of customer needs and alignment on applied strategy
- Establish and maintain -in alignment with Regional and Global Medical Affairs
- strong relationships with Key Opinion Leaders (KOLs) as well as establish network including medical, clinical and academic community, authorities, pharma industry, payers and other relevant stakeholders
- Establish and develop Medical Affairs Managers in the country including territory alignment, targeting and segmentation
- Develop HCP mapping and segmentation principles as basis of MSL territory alignment in coordination with commercial excellence where applicable; set standards for local/regional HCP mapping by MSLs
- Provide medical contribution to Tender Business offers and negotiations;
- Anticipate or identify changes in the marketplace that may provide scientific, medical, regulatory and/or commercial opportunities for Takeda
- Act as communication link between local Departments and Regional and global medical functions
- Supervise Medical Education, Publications, Insight Generation activities
- Responsible for the timely and competent handling of all scientific/medical aspects related to all marketed and developing Takeda products in accordance with appropriate international and regional Guidelines/Directives, local law and Takeda standards/SOPs
- Develop and oversee execution of medical training of LOC / MCO personnel
- Establish a KPIs system for MSLs and operationalize in CRM

**Clinical Research**
- Final responsible person for the development of clinical research plan (both interventional and non-interventional, including RWE) according to gap analysis and in alignment with Global and local functions (i.e. Patient Value and Access)
- Responsible for the scientific integrity, GCP adherence, (global) strategic alignment, safety, design, high quality and timely conduct of local clinical studies
- Oversee the evaluation and support of local Investigator Initiated Sponsored Research (IISR) proposals to ensure global strategic alignment and execution in line with Takeda standards
- Facilitate and support local GCP audits and inspections and oversee completion of GCP related commitments or CAPAs according to the agreed time lines.

**Quality Assurance**
- Support the implementation of Global PDD Standards and Standard Operating procedures (SOPs) that are aligned with local requirements
- Oversee development and maintenance of GxP related controlled documents in the local Quality Management System

**Regulatory Affairs**
- Nominate a local Regu

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