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  • Posted: Apr 7, 2023
    Deadline: Not specified
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  • Takeda has brought hope to people around the world through our people-centered and innovation-driven approach to science and medicine. As a global pharmaceutical leader, we focus on solving unmet needs where we can make a real difference-and on putting patients first. Our therapeutics focus is oncology, gastroenterology, and the central nervous system, as we...
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    Ethics & Compliance Lead

    Who we are looking for:

    • We are currently looking for a E&C Lead.  

    Objectives of this role:

    • The E&C Lead - South Africa, will support the South African business as LOC E&C Lead to enable Takeda to achieve its purpose and vision trough applying the values of Takeda-ism. Will act as role model for Takeda's values, ethics and values-based decision making, fostering this mindset with clients, partners, and the team.
    • Strong understanding on E&C Global, Regional and LOC mission and vision to collaborate and contribute to regional level initiatives and projects.
    • Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business. Will collaborate across the LOC and partner with stakeholders in MCO to embed ethics and compliance as part of the way everyone works at Takeda. Guide the business in shaping the organizational mindset around the PTRB (Patient-Trust-Reputation-Business)-Model to firmly embed ethical decision-making principles.           
    • Will lead the implementation and overseeing of a comprehensive E&C program across South Africa
    • Will establish a trust relationship with South African LOC to facilitate an open discussion of any potential risks and matters or areas of improvement.
    • Understand business risk from Enterprise Risk assessment perspective and have close relationship with other stakeholders to identify emerging risk and collaborate on mitigation actions.
    • Be able to have strong understanding on the day-to-day High Risk Business Activities and associated risk, conduct regular quarterly monitoring for those activities.

    Required qualifications and experience:

    • Bachelor’s degree, relevant advanced degree is preferred.
    • 5-7 years of proven experience in healthcare and healthcare compliance

    Accountabilities: 

    • Identify and escalate emerging risks in the market, propose the E&C program enhancements to UMEA E&C Head and Country Head, SA.
    • To ensure compliance with Takeda’s policies, industry codes and the applicable legislation and implementation of corrective actions to resolve issues.
    • Collaborate and work closely with UMEA E&C Head on Growth and Emerging Markets (GEM) and Global initiatives to lead projects and trainings across UMEA MCO when its needed.
    • Update the SA country management, stakeholders on E&C program developments, external industry trends and emerging risk areas.
    • Develop and roll out SA Policies, SOPs, procedures, and systems.
    • Develop, localize, deliver and track trainings for Takeda personnel and provide guidance, information & education on E&C-related matters. Track training programs and systems to support implementation of training and ensure follow up and reminders where needed.  
    • Execute the Takeda’s Monitoring and Enterprise Risk Assessment Program for SA and the timely resolution of audit findings and related remediation plans. Including the but not limited to Global quarterly monitoring, live monitoring, corrective and preventive actions tracking.
    • Implement and oversee and track Takeda’s Code of Conduct (CoC), Conflict of interest (COI) guidelines and Global Anti-Corruption Policy.
    • Implement, operate, and track policies, procedures, and systems for the approval of Advisory Boards, Congresses, Hospitality, Grants, Donations and Sponsorships, interactions with Patient Organizations, Samples etc. and all other relevant Global and Regional E&C policies, processes and systems.
    • Conduct or participate in local investigations to investigate violations or alleged violations of the Global CoC or any other relevant Takeda policies, industry Codes of legislation requirements in line with Takeda issue handling procedures in coordination with UMEA E&C Head.
    • Lead RECC committee regularly.
    • Ensure delivery of E&C support across LOC and MCO, counselling on a wide range of matters relating to anti- corruption and pharma industry codes and standards & local legal requirements as well as promoting ethical decision making and compliance with all relevant regulations to the highest standards of integrity.
    • Accountable for risk assessment and due diligence of Third-Party Management, PAPs, PSPs or any other programs and any related and required administrative steps.
    • Participate in SA Pharmaceutical Industry Compliance work groups to add input, gather and disseminate trends in applicable laws & regulations and healthcare best practice standards.
    • Lead the preparation and process for SA audits.
    • Follow-up on E&C related matters reported through the hotline or through other mechanism were required.
    • Build and maintain networks with colleagues across Takeda to identify areas of risk or knowledge deficiencies and develop and implement customised training strategies to meet those needs.
    • Support and guide the local CoC Values Ambassador Network.
    • Execute and collaborate on Takeda’s Third-Party Due Diligence Program and implementation of Enterprise Risk assessment.

    General

    • All employees are accountable for responsibilities stated in standards/SOPs for which training has been completed or included in employee’s training matrix

    Core competencies

    • Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business.
    • Creates the environment that inspires and enables people to move the organization forward.
    • Focuses on the few priorities that matter most and delivers superior results.
    • Elevates the capabilities of the organization for now and the future.
    • Acts as role model for Takeda’s values, ethics and values-based decision making.
    • Clear communication and strong interpersonal skills including the ability to challenge constructively while providing guidance to business and other stakeholders.
    • Able to build alliances, bridging from internal to external stakeholders critically appraising proposals / approaches identifying risks while presenting alternatives / solutions to the business.
    • Strong operations, process-orientation, attention to detail, or technical expertise to effectively design, develop and implement compliance and relevant business processes, SOP’s controls, and workflows are necessary.
    • Ability to work well between functions and across all levels of the business, influencing skills are essential.
    • Able to work and deliver on deadlines while managing multiple projects and priorities effectively.
    • Good knowledge and understanding of current compliance issues facing the pharmaceutical industry.
    • Demonstrates unquestionable integrity and professionalism.
    • Good communication skills, with the ability to network both within and outside the organization.
    • Problem solving abilities.
    • Ability to manage effectively in fast paced, changing environment.
    • Project Management.
    • Cross-Functional Team Management.
    • Global Thinking.
    • Excellent leadership, managerial, interpersonal and relationship building skills.

    Business skills and knowledge

    • Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business.
    • Creates the environment that inspires and enables people to move the organization forward.
    • Focuses on the few priorities that matter most and delivers superior results.
    • Elevates the capabilities of the organization for now and the future.
    • Acts as role model for Takeda’s values, ethics and values-based decision making.
    • Clear communication and strong interpersonal skills including the ability to challenge constructively while providing guidance to business and other stakeholders.
    • Able to build alliances, bridging from internal to external stakeholders critically appraising proposals / approaches identifying risks while presenting alternatives / solutions to the business.
    • Strong operations, process-orientation, attention to detail, or technical expertise to effectively design, develop and implement compliance and relevant business processes, SOP’s controls, and workflows are necessary.
    • Ability to work well between functions and across all levels of the business, influencing skills are essential.
    • Able to work and deliver on deadlines while managing multiple projects and priorities effectively.
    • Good knowledge and understanding of current compliance issues facing the pharmaceutical industry.
    • Demonstrates unquestionable integrity and professionalism.
    • Good communication skills, with the ability to network both within and outside the organization.
    • Problem solving abilities.
    • Ability to manage effectively in fast paced, changing environment.
    • Project Management.
    • Cross-Functional Team Management.
    • Global Thinking.
    • Excellent leadership, managerial, interpersonal and relationship building skills.

    Other requirements:

    • Valid South African Driver’s license for motor vehicle
    • Own vehicle that can be used for business.
    • Required overseas and local travel from time to time

    go to method of application »

    Therapeutic Area Lead: Gi/Ri

    Who we are looking for:

    • We are currently looking for a strong healthcare profile with the right attitude to join our Medical team in the role of Therapeutic Area Lead: Gastroenterology (Gi)/ Rare Immunology (Ri).

    Objectives of this role:

    • Responsible for developing and managing the medical strategy for specific therapeutic areas (TA)/ brands and integration of this strategy into the brand plan\s.
    • In-house scientific expert for the specific TA continually reviewing relevant and current scientific literature and providing up-to-date, fair-balanced product-related and clinical information relevant to the TA to internal and external stakeholders.
    • Establish, develop and foster relationships with key external stakeholders through scientific discussions to facilitate and contribute to insight generation, in-depth understanding of the patient journey within specific therapeutic areas (TA) that eventually guides the creation of the medical plan which enables greater access and capability building across the treatment pathway.
    • Assist the Head Medical Affairs in all matters related to medical governance and compliance within the medical function, by putting the patient’s needs and safety into focus.

    Required qualifications and experience:

    • Advanced scientific or clinical degree ex: MBChB; Master’s Degree in Life Sciences, PharmD, or Ph.D 
    • Preferably 2+ years clinical practice
    • Preferably 2+ years gastroenterology experience with established relationships in market.
    • Preferably 2+ years of experience in driving and managing the medical strategy for various brands in the pharmaceutical industry

    Accountabilities: 

    • Key Opinion Leader (KOL) engagement, partnerships with professional societies & Non-Government Organisations (NGOs)
    • Education and training initiatives enabling early disease identification and optimal management to improve Standards of Care (SoC)
    • Deliver medical / scientific messages relating to product data and disease to selected Key Opinion Leaders identified through stakeholder mapping and according to defined stakeholder engagement plans.
    • Partnerships and scientific support to develop Centres of excellence (CoE)
    • Global partnerships through preceptorships, & scientific engagements to enhance skills and capability across the healthcare system
    • Clinical trial opportunities to drive early experience and advance patient access to medicine pre-registration
    • Support and drive Real world evidence (RWE) data generation (internal and external data)
    • Contributing to the organization through medical expertise:
    • Apply scientific expertise and customer (patient and prescriber) insights to contribute to the development of the Brand Strategy and develop a Medical Plan for each assigned product.
    • Ensure excellence and timeliness in implementation of the therapeutic area specific medical plans
    • Establish scientific engagement plan aligned with the TA medical Plan to guide in-field activities (e.g. scientific platform content, presentation of new data)
    • Formulate strategic KOL/Stakeholder engagement plans to inform and assist in evaluating innovative ideas in development of the medical strategy
    • Evaluate execution of plans on an ongoing basis and adapt where necessary to improve
    • Respond to unsolicited requests from HCPs for medical information (including off-label information) related to marketed Takeda products and Takeda pipeline products
    • Review and approve promotional materials as per Takeda policies
    • Develop medical/scientific materials and slide decks as needed (e.g. Advisory board slides) and ensure the content is appropriately reviewed and approved as per Takeda policies
    • Support scientific training of internal stakeholders and provide ongoing support and education as needed
    • Building capabilities:
    • Develop and maintain up-to-date knowledge of the TA by reviewing the literature, engaging in ongoing scientific exchange with KOLs and other external stakeholders, attend relevant scientific congresses
    • Develop a TA specific scientific engagement plan aligned with the TA medical Plan to guide in-field activities (e.g. scientific platform content, presentation of new data)
    • Deploy effective measures to complete tasks within time frame
    • Collaborate and participate in cross functional teams to work towards achieving objectives set out in brand plans at a local and regional level where required.
    • Managing and Engaging External Stakeholders:
    • Have a clear understanding of external stakeholder mapping, which will enable development of appropriate and relevant relationships and build networks to meet business objectives
    • Work with key stakeholders to gain a comprehensive understanding of the patient journey and how it may evolve in the future
    • Drive Scientific leadership through facilitation of meetings & events with clinical experts to strengthen capacity, improve referral pathways and provide higher quality of care
    • Be customer centric in all actions, listening to spoken and implied feedback and responding in a timely manner
    • Complying with external regulations and company policies for a best-in class medical contribution for the patients and TA:
    • Have a good understanding of global and local regulations and company policies and how to conduct all activities within that framework
    • Ensure that all scientific-medical communications are fair-balanced, based on appropriate scientific evidence, and compliant with local regulatory norms and internal compliance policies
    • Prioritize patient safety by following all Pharmacovigilance (PV)-related processes
    • Assist the Medical Affairs Head in proactive risk management and recognize when appropriate actions need to be put into place or highlighted
    • Always uphold the Company’s reputation
    • Responsibilities relating to Health System Strengthening (HSS), Patient Services and Patient Advocacy:
    • Support and identify Healthcare System Strengthening initiatives and projects
    • Provide local, operational support for the Patient Services function, specifically Patient Support Programs
    • Interact with, develop and support Patient Advocacy groups and Advocacy initiatives
    • Other duties include:
    • Provide timely, accurate and balanced answers to unsolicited medical enquiries when required
    • Collaborate with Regional and Global Medical Information
    • Liaise with Clinical Research Organisations (CROs) and other vendors for Takeda sponsored global studies as appropriate
    • Collaborate with Global Development Operations functions (e.g. LOC Support)
    • Deliver medical strategy and allocate spend associated with this investment and use of resources to implement strategy
    • Track/monitor field medical activities in align with activity specific KPIs
    • Review of promo materials and creation of non-promotional materials/ programs to ensure they are on strategy, meet regulatory and internal SOP requirements
    • Evaluate profile of KOLs utilizing objective, pre-approved scientific criteria to ensure    selection of KOLs, and associated engagement plans and actual engagements are in line with brand strategy and compliance framework

    General

    • All employees are accountable for responsibilities stated in standards/SOPs for which training has been completed or included in employee’s training matrix

    Core competencies

    • Foster and sustain a valued continuum of professional interchange with major external stakeholders, & their organisations to advance scientific, medical and patient care excellence.
    • Integration of the latest scientific and medical knowledge together with likely future developments to identify needs and then create solutions to build capabilities within the healthcare system
    • Lead the development and approval of clear and practical plans that will assist this transformation

    Business skills and knowledge

    • Communication (verbal and written) skills,
    • Ability to form a balanced opinion considering a wide range of medical and scientific information

    Other requirements:

    • Own vehicle that can be used for business.
    • Required overseas and local travel from time to time
    • Time spent in field, relationship management, insights gathering and calling on Key Account Leader in both Public and Private is split 50% in field and 50% Office Based

    Method of Application

    Use the link(s) below to apply on company website.

     

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