Website: Website http://www.roche.com

Field Service Engineer Call Center Specialist

Roche Diagnostics in Nairobi, Kenya is seeking a Field Services Engineer to provide diagnostic instrumentation post-sales technical support in accordance with the manufacturers specifications and Roche Diagnostics standards.
Key Responsibilities:
Technical Support

Resolve/take accountability for cases by receiving case, contacting client, providing telephonic support (if possible) and coordinating resolution of case within SLA/deadline.
Provide technical support on site by coordinating appointment to resolve case with key contact at customer, organizing required parts and equipment and providing support within deadline / SLA.
Coordinate resolution of escalated technical cases by identifying issues that require escalation, referring to appropriate escalation process, providing feedback to customers, internal sales and line manager, following up until resolved and closing case within customer expectations.
Follow-up with customers after cases are closed by contacting clients via telephone or email, verifying case is fully resolved, reopen/open cases if the issue is reoccurring and resolve within deadline.
Proactively provide technical support to customers by receiving adhoc customer support requests while on site, after hours etc., by receiving request for support from customer, logging case on system, providing technical support and closing case or distributing case correctly immediately.

Modifications
To conduct modifications by receiving notification of modification/enhancements, upskilling on technical requirements, contacting customers to schedule modification and conducting as per specifications and standards and within deadline To manage the modification projects by engaging with internal stakeholders and providing technical guidance on.
Installations & De-Installations

Initiate installation / de-installation projects by being appointed as project installation lead, engaging with Project Manager, agreeing installation requirements and specifications, conducting site inspection, understanding customer expectations and requirements and developing installation plan within deadline.
Conduct installation /de-installation by preparing all equipment and parts and installing system according to specifications, installation manuals and standards within deadline and as per plan.

Customer Service Support

Maintain a customer centric approach with all customer engagements by aligning with the Roche values, maintaining professionalism, providing quality technical support and advice and delivering according to their expectations and SLA at all times.
Proactively resolve customer issues by conducting courtesy visits, identifying potential issues and resolving and taking preventative action at all times.

Administration

Provide customers with all case relevant documentation by completing case reporting, collating documentation and issuing (email/print and issue) to the customer within deadline.
Manage customer support stock levels (boot-stock) by reconciling stock, recording stock utilisation, ordering additional stock, complying with the used and unused returns authorisation and the stock control processes at all times.
Address stock discrepancies by identifying inconsistencies, refer to relevant department for resolution and follow-up until resolved monthly.
Complete expense reporting by complying with the T&E policy and system requirements monthly and as required.
Complete overtime reports by capturing overtime, signing and submitting by deadline monthly.
Maintain an up to date and accurate planning board and team planner by capturing daily and long term planned activities according to standards and by daily deadline.
Maintain technical compliance standards by completing e-learning modules or training and achieving required compliance standards as required and within deadline.
Maintain tools of trade by verifying and maintaining calibration and storing and maintaining according to specifications and standards at all times.

You, as an ideal candidate, will have the following skills, experience and education:

Essential: Diploma in Electrical Engineering or Mechanical Engineering or Biomedical Technology or equivalent.
Experience: 2-3 years technical support services experience – medical diagnostic industry experience is preferred.
The successful candidate needs to be in possession of a valid drivers license and have a valid passport (within 3 months of employment)

Job Level:
Individual contributor

go to method of application »

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

Apply via :

October 28, 2024
IT Field Service Engineer

Roche in Nairobi, Kenya is seeking an IT Field Service Engineer for the Diagnostics portfolio, to provide diagnostic instrumentation post-sales technical support in accordance with the manufacturers specifications and Roche Diagnostics standards.

Key Responsibilities:

Technical Support

Support clients technical support needs by advising on the systems and products in line with global requirements and by installing computer hardware and software in line with client needs and relevant SOPs.
Identify system problems by troubleshooting, analysing the issues, conducting research and recommending relevant solutions.
Plan for installations and sourcing of required boot/car stock (IT hardware, software and associated materials and equipment) by preparing warehouse requisition documentation and receiving the stock well before the scheduled installation as required.
Support installations and upgrades by implementing relevant computer hardware and software solutions in line with manufacturing standards for installation and upgrades.
Support full registration of software with GCS (Global) and full integration of computer hardware and software systems for relevant diagnostic instrument/s with the relevant LIS (laboratory Information System) by complying with the correct communication protocols.
Support resolution of complex problems by escalating the related challenges to relevant stakeholders and follow up on their resolution in line with company policy or SOPs as required.
Support complex IT installations by providing IT project management support for related technical work.
Provide Electronic Field (Case) Service Reports by completing the report and sharing it with the relevant stakeholders within 24 hours of completion of allocated work.

Stakeholder Management

Serve clients and stakeholders by adhering to client service level agreements deliverables & department planning and activities roster (including timelines) in respect of IT support services.
Maintain a high level of customer engagement by conducting visits to client sites and providing regular feedback on IT hardware and software elements.
Support technical knowledge of clients and other stakeholders by providing relevant training on the IT software program/s and/or reporting applications, advising business areas with relevant IT hardware and/or software knowledge and specifications and providing IT assistance to cross-functional teams.

You, as an ideal candidate, will have the following skills, experience and education:

Essential: A diploma or degree qualification in Information Technology/ Information Systems/Systems Development or equivalent.
Experience: 3- 5 years’ experience in IT hardware and software technical configuration support
The successful candidate needs to be in possession of a valid drivers license and have a valid passport (within 3 months of employment)
Required knowledge: Service CRM case management systems (logging case details).

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Head of SADC

Roche Diagnostics in Midrand seeking a Head for our SADC region. The role will entail leading the SADC organization by developing and implementing short and long term strategies in alignment with Management Center South Africa to ensure that Roche Diagnostics retains and advances it’s leadership position in SADC, ensuring that Roche values of Courage, Passion and Integrity are instilled across all teams.
Key Responsiblities

Play a leading role as a member of the sub-Saharan Management team, to define and implement the overall sub-Sahara Vision and Strategy
Develop and implement strategic plans for SADC in line with that of Management Center South Africa
Define and attain needed resources and competencies to ensure Roche Diagnostics is able to achieve its short and long term Strategic and Financial objectives
Drive and foster culture of cross collaboration with other sub-Saharan Markets and the Management Center South Africa
Play a leading role in local and corporate compliance and promote ethical behavior, in compliance with laws, regulations, industry codes, policies and procedures
Ensure Roche Values are instilled across the Organization
Ensure the effective Management of Business Partners in line with Roche values and objectives
Build relationship with key stakeholders and Key Opinion Leaders to position Roche as a leader in the IVD market
Build and foster relationship across Roche Divisions in SADC, leveraging the One Roche approach
Manage team through effective recruitment, induction, skills development, performance coaching and evaluation in line with HR policies and procedures and Roche Leadership Commitments
To draft and present reports by gathering information, analysing and interpreting data, identifying trends and patterns and submitting reports for review and approval annually and as required

You, as an ideal candidate, will have the following skills, experience and education

Qualifications University Degree or Professional Medical Degree, (MBA or post graduate studies are a plus)
Experience At least 5 years Senior Leadership experience in Marketing, Sales or Finance in the Medical Diagnostics, Pharmaceutical or Healthcare space

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Medical Lead, Pan Africa – Non-Communicable Diseases

Roche is seeking a Medical Lead for Diagnostics. This is a Pan-African position reporting into the Medical and Government Affairs Department of Roche Diagnostics EMEA-LATAM. This person will serve as a point of contact for all Medical Affairs topics within a Pan-African context. The focus for this role is to shape and implement the regional medical strategy in collaboration with Roche internal and external stakeholders including academic institutions and scientific organizations (eg: ASLM, WHO Afro, Africa CDC) and related local agencies/NGOs. This person will engage with regional customers and other healthcare stakeholders, develop relationships with African region therapeutic areas experts, provide guidance and alignment according to African regional health priorities and provide support for the local affiliate medical teams. This will be done within the context of the One Roche Africa Strategy and in close collaboration within the African region, EMEA-LATAM region and global medical- and commercial teams.

The role will be based on the continent (e.g. Kenya or Nigeria for Anglophone and Dakar or DRC for Francophone Africa) in order to drive regional interests and to enable travel to countries across the continent. This role has both strategic and tactical elements to support medical focus initiatives with a focus on non-communicable diseases (NCD) that span Core-Lab and Pathology priorities across Africa.
Key Responsibilities:

Medical Management
Contribute to and support the evolution of clinical guidelines and algorithms by establishing and maintaining relationships with relevant HCO, HCP’s and Professional- and Academic Organizations/Bodies.
Support the development and implementation of an economic and medical value strategy to position assigned products with funders and policy makers by providing scientific input to the regional health care systems.
Contribute to and implement the African regional medical strategy in line with the One Africa strategy.
Monitor scientific and medical compliance in accordance with the company compliance standards and MedTech codes by overseeing that the standards are met and that the necessary approvals are obtained.
Work within the African network to co-develop the African region medical tactical plans based on the prioritization and addressing any areas of concern or missing information for localisation.
Monitor performance against strategy and tactical plan by providing progress reports, analysing the progress, addressing any areas of non-performance and implementing corrective action.

Stakeholder Management

Support affiliate medical and commercial teams in local activities enabling access to medically differentiated products and support health system strengthening initiatives. Such projects include the One Roche Cancer Diagnostics strategy, Women’s Health, UHC, NCDs and local affiliate pilot projects and studies.
Plan and execute relevant scientific exchange with internal and external experts to leverage existing evidence to expand access for the benefit of the populations we serve.
Manage relationships with key stakeholders by identifying appropriate forums for engagement and providing feedback and information as required and by identifying and managing Therapeutic Area Experts for specific diseases as required within the areas of focus for the role
Contextualize the medical value proposition and activities by developing the materials in a fair and balanced approach and in compliance with regulations and company SOP’s, communicating to required stakeholders through appropriate platforms.

Training & Development

Develop the training plan by reviewing the training gaps identified, collating the requirements across the therapeutic area internally and externally and approving the training plan.
Educate on disease and key products in designated markets and in alignment with the regional Africa strategy by reviewing input materials, validating against international and local standards in line with regulatory requirements.
Support knowledge sharing on marketing strategies for key products by advising and updating the product management team with relevant market dynamics and medical insights.
Conduct training and monitor training effectiveness by verifying the training materials, preparing presentation and facilitating the training sessions both internally and externally.
Act as a coach to local/affiliate medical team colleagues and provide feedback on training needs based on interactions with the local and regional team.

Healthcare Development

Drive the development of Regional Disease Area Networks by bringing together medical, access, governmental, commercial and strategic expertise in collaboration with regional stakeholders (Medical & Governmental Affairs, Affiliates, etc.).
Be a catalyst for affiliate implementation of disease management initiatives by building and engaging country networks and capability building at affiliate level.

Drive TAE management and strategic partnerships together with affiliates to validate and support patient journey approach, identify portfolio gaps, and develop external advocates.
Define, implement and track key healthcare development or patient outcomes associated with disease management plans.
Identifies gaps & opportunities in patient journeys from different stakeholder perspectives (HCP, patients, caregivers) to define value pools for commercialization of on-market portfolio.
Support and collaborate with the One Roche Africa and EMEA-LATAM Region Market Access and Policy teams by undertaking or facilitating required research.
Support Investigator initiated studies and Roche sponsored studies by evaluating the need for the study, facilitating approval and assisting with the study implementation as required in support of local/affiliate teams.
Manage clinical trials and contracts by monitoring progress, tracking budgetary information, managing delivery against deadlines and addressing any areas of non-compliance.
Identify and develop effective peer-to-peer relationships to execute Roche product strategies in line with company SOP’s, local and international regulations and ethical compliance by undertaking research and providing expert opinion medical recommendations on scientific medical information.
Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes by reviewing the information, identifying any problem areas, addressing and resolving as required.

Impact

Contribute to African regional / EMEA-LATAM and global objectives and global growth and increased patient access across Africa.
Deliver key initiatives that result in changes to African regional or local medical guidelines leading to greater access within agreed timelines.
Develop of key relationships within the African healthcare ecosystem to shape medical agendas in alignment with strategy.

You, as an ideal candidate, will have the following skills, experience and education:

Required Qualification: Medical Doctor or PHD in a relevant clinical or scientific field.
Required Experience: 2 – 5 years experience in health sciences or equivalent with strong proven therapeutic area experience in Cardio-metabolic / NCD.
Must have knowledge of: Healthcare Laws and Regulations, Medical knowledge of relevant strategic products.
Language requirements: English required. Additional French is preferred

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Health Policy & Access Partner, Africa Program Coordinator – African Genomics Program Data Scientist – African Genomics Program

The focus for this role would be to bring global policies to local levels to shape and influence implementation across the continent through support of affiliate teams. The role would be based on the continent (e.g. Nairobi or Addis Ababa) for consistent engagement with regional and/or local stakeholders who have regional influence and to enable travel to countries across the continent as needed. This role has both strategic and tactical elements to support initiatives that span multiple countries and for linkage at the regional level with Roche Pharma and Diabetes Care colleagues. This role is about the “how” and the “what” in regional health policy.

The Access and Policy Partner , Africa will focus on global health policy and government affairs topics across the African continent and across Roche’s divisions.

The successful incumbent will serve as a point of contact for health policy for Africa to regional intergovernmental organizations (eg: African Union, OAFLAD, Africa CDC) and related local agencies/NGOs (Amref, CHAI). This person will engage with regional level stakeholders, provide insights into African regional health priorities and policy agendas and provide support for the local affiliate policy teams. This will be done within the context of the One Roche Africa Policy and Partnership Squad and a team effort together with other policy roles.

This person will bring insights into the political and economic healthcare ecosystem for key regions on the African continent, build strong relationships with regional or national stakeholders that influence across multiple countries and advocate for patient access to healthcare no matter where they live.

Responsibilities include:

Build a deep understanding of the health ecosystems across the African continent to set policy agenda priorities including the environments, institutional and political landscapes with emphasis on key priority countries linked to the One Roche Policy and Partnership strategy .
Actively engage and build relationships with political stakeholders and key influencers of health policy agendas at regional and national levels in coordination with global health policy lead and the One Africa Roche Policy and Partnership Squad to enable removal of barriers and bring key disease area and health topics to the priority agenda for rapid, broad and sustainable access to Roche innovations for patients.
Conduct research, analyze current healthcare policies, evaluate the effects of proposed legislation, and reporting on findings within the One Roche Africa Policy and Partnership Squad, EMEA LATAM region and Area Africa to identify unmet needs and opportunities.
Influence political and social events to increase voice around healthcare issues related to key business initiatives under the strategic initiatives of Roche in Africa both internally and externally.
Build supporting tools and knowledge resources (eg best practice) for implementation of policy agenda at local levels that deliver clear, evidence-based and compelling positions for governments and key influencers including financial aspects (eg pricing, business models), monitoring and evaluation metrics to track momentum for access and lessons learned and communication mechanisms (eg communities of practice).
Support affiliate policy and commercial teams in local activities in minimizing gaps/hurdles to access in support of health system strengthening initiatives and public private partnerships. Such projects include Global Access Program, One Roche Cancer Diagnostics strategy, Women’s Health, UHC, NCDs and local affiliate pilot projects for access.
Member of One Roche Policy and Partnership Squad for Africa, One Africa Policy and Partnership team, EMEA LATAM Governmental Affairs team and interface with Pharma Global Access Policy team and Communication teams for coordination in the co-creation of Africa health policy leading to greater regional government support for health development activities.

Impact will be measured by:

Contribution to regional/area business objectives, regional/area business growth and increased patient access across Africa.
Delivery of key initiatives that result in changes to regional or local policies leading greater access within agreed timelines.
Development of key relationships within the African health policy ecosystem to shape policy agendas.
Creation of health policy engagement and shaping capabilities within the local teams across Africa

Experience Needed:

Bachelor’s degree in Public health, Health Administration, Health Economics, Political Sciences or Public Policy. Graduate Degree (Health Policy, Health Economics, Public Policy, MBA) preferred.
Proven work experience of 5-7 years in government affairs, policy, public or corporate affairs preferably with some years of experience in the Pharma/diagnostics industry in LMICs/Africa.
Experience in working with political or governmental organizations and decision-makers to advance the public health conversation.
Understand political decision making and complex networks of influence and leverage negotiation skills.
Interpersonal skills for successful collaboration within highly matrixed cross-functional teams .
Critical thinking, strategic mindset, problem solving, and analytical skills.
Ethical mindset and good understanding of relevant compliance principles and regulations.
Strong influencing and negotiation skills: confirmed abilities to influence others without authority and mobilize people behind a common purpose and strategy.
Excellent command of English. French and/or Portuguese a plus.
Ability to travel across Internationally.

go to method of application »

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

Apply via :

October 28, 2024
Credit Controller

Roche Diagnostics in Midrand is seeking a Credit Controller to process customer accounts receivables on a daily and monthly basis to ensure timeous payment of statements in line with credit limits and credit terms.
The role will entail

Following up on outstanding accounts and carrying out reconciliation of debtors accounts
Assessing credit worthiness of customers using external information available from relevant sources and reviewing credit limits and payment terms granted on a periodic basis and making recommendations to management
Checking bank statements daily and allocating monies to relevant debtors’ accounts
Booking credit notes on the system in accordance with SOPs
Liaising with the outsourced (UTI) debtors team to address queries and complete reconciliations for accounts managed by them
Produce and review age analysis reports and follow up with debtors for payment
Providing debtors account information for external auditors
Providing daily confirmation of foreign receipts to CITI Bank for SARB reporting
Addressing customer queries with internal customers

You, as an ideal candidate, will have the following skills, experience and education

National Diploma in Financial Accounting or Bookkeeping or related (NQF level 6 and upwards) / ideally studying towards a BCom or related qualification (NQF 7)
At least 3 years accounts receivable control / financial accounting experience
At least 1 year experience with export related credit control

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Regulatory Policy and Intelligence Manager

Job Description
Roche in Nairobi is seeking a skilled leader to fill the position of Regulatory Policy and Intelligence Manager for Diagnostics to build and maintain a highly collaborative function for gathering and communicating regulatory intelligence, identifying and analysing changes in the regulatory environment, collaborating with Global Regulatory Policy & Intelligence to adapt global Roche Diagnostics’ regulatory policy positions to Africa and creating and executing strategic advocacy plans to achieve Roche Diagnostics’ regulatory policy goals. The position provides oversight and direction, and works collaboratively with stakeholders and subject matter experts, to influence the policy environment established by African regulatory authorities. The role entails leading and managing the Regulatory Intelligence management process for the Diagnostics Management Centre.
Key Responsibilities
Development of Policy Strategy

Provision of oversight and direction to the Diagnostics Management centre on regulatory policy, strategy, and influencing efforts such that Roche Diagnostics is recognized as an industry leader with health authorities and industry peer groups.
Overseeing the development and maintenance of a current picture of regulatory policy in Africa, including analysis of processes and issues, their impact on Roche Diagnostics, and the pathways for influencing such policy.

RPI Processes

Leading and directing an active regulatory intelligence function that gathers, analyses and communicates up-to-date information regarding regulatory policy activities and trends for Africa. Working with global RPI to ensure timely identification and reporting of regulatory intelligence to the Business and Global Functions. Ensuring the notification of final changes consistent with Global Standard Processes.
Ensuring effective internal processes for selecting and prioritizing issues on which Roche Diagnostics will focus its regulatory policy and advocacy efforts. Partners with subject matter experts and internal stakeholders to evaluate and develop positions and advocacy plans regarding proposed laws, regulations, guidance, policies and standards issued by national and/or regional regulators.

Relationship Management

Managing responses to proposed laws, regulations, guidance and standards submitted directly by Roche Diagnostics, as well as through industry organizations and coalitions. Collaborating with global RPI as needed to ensure consistent messaging and positioning.
Partnering with external stakeholders and allies, as appropriate, to build alignment with Roche Diagnostics’ regulatory policy positions and encourage external advocacy efforts consistent with those positions. (e.g., non-profit associations, industry organizations, think tanks, coalitions)
Fostering relationships based on trust and respect with key health authorities, and facilitates engagement with regulators on key topics of interest to Roche Diagnostics. Seeks to establish Roche Diagnostics as a trusted partner with health authorities.

Internal Collaboration

Collaborate closely with Government Affairs and other key stakeholders within Roche Diagnostics to ensure alignment on regulatory policy goals, policy positions, and advocacy efforts, as well as a consistent approach across regulatory, administrative and legislative arenas.
Serve as a key point of contact on Roche Diagnostics’ regulatory policy matters in Africa, and as representative at industry and coalition meetings related to regulatory policy and advocacy in Africa.

Communications

Communicate specific regulatory and quality trends, analysis and intelligence to global RPI and collaborate with Global RPI to communicate with Quality and Regulatory staff and Roche Diagnostics’ Leadership, as needed.
Partner with Q&R and subject matter experts to facilitate implementation of changes to Roche Diagnostics Divisional Standards, policies, procedures or practices based upon changes in the regulatory environment.

Training

Provide training and support for Q&R teams and others as needed, on key regulatory policy issues, directional changes in regulation, and trends in the regulatory environment.
Provide training to build capacity across Africa for influencing the regulatory environment.

Continuous Improvement
Monitor and develop measures to determine the impact of Roche Diagnostics’ regulatory policy strategies.
You, as an ideal candidate, will have the following skills, experience and education:

Qualifications: Advanced Degree, preferably in Pharmacy.
Experience: At least 10 years regulatory experience in the diagnostics/medical device industry, with demonstrated expertise in the areas of regulatory policy, advocacy and intelligence.
Other requirements: Subject matter expert in regulatory processes, laws and regulations, with a strong understanding of both the informal and formal aspects of how regulatory policy is shaped and developed, thorough knowledge of Africa regulatory including Health Authorities, Health Authorities staff and Health Authorities policies; complete understanding of the Africa Health Authorities Acts and associated regulations and guidance, proven ability to develop innovative regulatory strategies and key positions on regulatory policy topics of interest.

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Market Access Manager – East Africa & West Africa (2 Year Contract)

About the job

Roche Diagnostics in either Lagos, Nigeria or Nairobi, Kenya is seeking a Market Access Manager for East and West Africa for a 2 year fixed term contract. The successful incumbent will drive the development of Health Ecosystems by developing and implementing market and patient access strategies to drive optimal access to strategic healthcare solutions in the public and private sectors. The requirement will be to support the mid to long-term Healthcare Transformation strategy by supporting the development and implementation of stakeholder engagements, partnerships and other health systems strengthening projects.

Key Responsibilities:

Understanding and Development of Health Ecosystems

Build a deep understanding of the health ecosystems with an emphasis on diagnostics across the focus markets within the territory. This understanding should include health system operating environments, institutional and political landscapes.
Undertake necessary research and analyze current healthcare policies to understand health issues and market trends shaping the future of health ecosystems.
Leverage this knowledge to understand policy priorities and current barriers to access with a focus on drafting the strategy, aligning with the overall long-term organisational strategy and vision annually.
Actively engage and build relationships with political stakeholders and key influencers of health policy agendas at regional and national levels in coordination with the Government Affairs & Access Lead to enable removal of barriers and to bring key disease areas and health topics to the priority agenda, driving sustainable access to Roche innovations for patients.

Market Access Management

Execute an integrated access plan across public and private sectors by analysing the strategies and environments and engaging with key stakeholders and finalising the plan annually.
Build innovative market access solutions by researching global trends, analysing trends in the context of the specific environments, testing solutions, engaging with experts, piloting solutions and managing implementation of successful innovations.
Build supporting tools and knowledge resources (e.g. best practice) for the implementation of access and policy agenda at country levels that deliver clear, evidence-based and compelling positions for governments and key influencers including financial aspects (eg pricing, business models), monitoring and evaluation metrics to track momentum for access and lessons learned and communication mechanisms (eg communities of practice).
Support cross-functional teams within both Diagnostics and Pharma affiliate in activities to minimize gaps/hurdles to access in support of health system strengthening initiatives and public private partnerships. Such projects could include Roche regional programs, (e.g. Global Access Program), One Roche Programs, or local pilot projects for access.

Support of broader Healthcare Transformation Projects

Work cross-functionally with other members of the Healthcare Transformation Team including Roche Healthcare Consultants, Strategic Program Managers, as well as members of the Medical, Marketing and Sales teams to drive and deliver projects aimed at transforming Healthcare in focus markets.
Participate in the co-creation of Integrated Solutions Plans.
Participate in the definition and establishment of medium to long-term partnerships (both Private-Private and Public-Private approaches) that drive increased access to Roche’s innovative products and drive broad-based health systems strengthening.
Participate as implementer within projects defined under the Integrated Solutions Planning process (ISP) where policy and/or access subject matter expertise and experience are needed.

Financial Management

Contribute to the preparation of the department budget by identifying activities and costs, preparing the budget and submitting it annually and as required.
Monitor expenditure by tracking spend against budget allocations, providing input into approval of expenditure, addressing any budget variances and providing feedback as required.

A full job description will be made available to candidates invited to the interview process.

You, as an ideal candidate, will have the following skills, experience and education:

Required Qualification: NQF 7/8 in a Clinical or Science related field.
Required Experience: 3-5 years experience in Government Affairs or Market / Patient Access with 1-2 years experience within a Pharmaceutical or Diagnostics environment.
Other Requirements: The willingness to travel both locally, in Africa and Internationally.
Essential Knowledge: Healthcare laws and regulations, policy and regulatory landscapes in LMIC / Africa.

Apply via :

roche.wd3.myworkdayjobs.com

October 28, 2024
Regulatory Policy and Intelligence Manager EpiCX Data Governance Lead Talent Acquisition Partner – AoP Recruiting (Subregion EEMEA) – Czech Speaker

Roche in Nairobi is seeking a skilled leader to fill the position of Regulatory Policy and Intelligence Manager for Diagnostics to build and maintain a highly collaborative function for gathering and communicating regulatory intelligence, identifying and analysing changes in the regulatory environment, collaborating with Global Regulatory Policy & Intelligence to adapt global Roche Diagnostics’ regulatory policy positions to Africa and creating and executing strategic advocacy plans to achieve Roche Diagnostics’ regulatory policy goals. The position provides oversight and direction, and works collaboratively with stakeholders and subject matter experts, to influence the policy environment established by African regulatory authorities. The role entails leading and managing the Regulatory Intelligence management process for the Diagnostics Management Centre.

Key Responsibilities

Development of Policy Strategy

Provision of oversight and direction to the Diagnostics Management centre on regulatory policy, strategy, and influencing efforts such that Roche Diagnostics is recognized as an industry leader with health authorities and industry peer groups.
Overseeing the development and maintenance of a current picture of regulatory policy in Africa, including analysis of processes and issues, their impact on Roche Diagnostics, and the pathways for influencing such policy.

RPI Processes

Leading and directing an active regulatory intelligence function that gathers, analyses and communicates up-to-date information regarding regulatory policy activities and trends for Africa. Working with global RPI to ensure timely identification and reporting of regulatory intelligence to the Business and Global Functions. Ensuring the notification of final changes consistent with Global Standard Processes.
Ensuring effective internal processes for selecting and prioritizing issues on which Roche Diagnostics will focus its regulatory policy and advocacy efforts. Partners with subject matter experts and internal stakeholders to evaluate and develop positions and advocacy plans regarding proposed laws, regulations, guidance, policies and standards issued by national and/or regional regulators.

Relationship Management

Managing responses to proposed laws, regulations, guidance and standards submitted directly by Roche Diagnostics, as well as through industry organizations and coalitions. Collaborating with global RPI as needed to ensure consistent messaging and positioning.
Partnering with external stakeholders and allies, as appropriate, to build alignment with Roche Diagnostics’ regulatory policy positions and encourage external advocacy efforts consistent with those positions. (e.g., non-profit associations, industry organizations, think tanks, coalitions)
Fostering relationships based on trust and respect with key health authorities, and facilitates engagement with regulators on key topics of interest to Roche Diagnostics. Seeks to establish Roche Diagnostics as a trusted partner with health authorities.

Internal Collaboration

Collaborate closely with Government Affairs and other key stakeholders within Roche Diagnostics to ensure alignment on regulatory policy goals, policy positions, and advocacy efforts, as well as a consistent approach across regulatory, administrative and legislative arenas.
Serve as a key point of contact on Roche Diagnostics’ regulatory policy matters in Africa, and as representative at industry and coalition meetings related to regulatory policy and advocacy in Africa.

Communications

Communicate specific regulatory and quality trends, analysis and intelligence to global RPI and collaborate with Global RPI to communicate with Quality and Regulatory staff and Roche Diagnostics’ Leadership, as needed.
Partner with Q&R and subject matter experts to facilitate implementation of changes to Roche Diagnostics Divisional Standards, policies, procedures or practices based upon changes in the regulatory environment.

Training

Provide training and support for Q&R teams and others as needed, on key regulatory policy issues, directional changes in regulation, and trends in the regulatory environment.
Provide training to build capacity across Africa for influencing the regulatory environment.
Continuous improvement
Monitor and develop measures to determine the impact of Roche Diagnostics’ regulatory policy strategies.

You, as an ideal candidate, will have the following skills, experience and education:

Qualifications: Advanced Degree, preferably in Pharmacy.
Experience: At least 10 years regulatory experience in the diagnostics/medical device industry, with demonstrated expertise in the areas of regulatory policy, advocacy and intelligence.
Other requirements: Subject matter expert in regulatory processes, laws and regulations, with a strong understanding of both the informal and formal aspects of how regulatory policy is shaped and developed, thorough knowledge of Africa regulatory including Health Authorities, Health Authorities staff and Health Authorities policies; complete understanding of the Africa Health Authorities Acts and associated regulations and guidance, proven ability to develop innovative regulatory strategies and key positions on regulatory policy topics of interest.

A full job description will be provided to candidates attending an interview.

go to method of application »

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

Apply via :

October 28, 2024
Country & Study Start-up (SSU) Manager

The position
Country & Study Start-up (SSU) Manager, Kenya who will function as a subject matter expert on all SSU and Clinical Trial Management related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies. As a Country Study Manager, this role will provide direction and leadership to one of more local study teams (LSTs).
The role entails the following responsibilities:

Coordinate guide and assist with all study start up activities prior to site activation.
Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up activities.
Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
Track metrics and study start-up timelines to identify trends and opportunities for improvement
Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
Establishes Study Timelines, Budget, Resource, Risk and Quality Plans
Manages the Delivery of Study Activities in Order to Meet Study Plans
Is accountable for all local CCO regulatory, ethical and administrative submissions
Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSM, functional management

Who you are
You are passionate about the impact on patients you can have, you are playful with the uncertainty the dynamics of the country served will bring whilst you will stay your course towards the long-term vision? You are a self-starter and energized by new learning opportunities the cultural and market environment will provide you? Then you are the individual we look for. In order to set you up for success you require the following qualifications, Mindset and Behaviors

University degree or equivalent in a medical/science-related field and or 5 years proven experience in Clinical Research Management or related industry.
Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
International travel required.
Good stakeholder management and the ability to effectively collaborate across a global organization.
Ability to influence, act as a change agent, build consensus and manage conflict in challenging situations.
Ability to work as part of a team.
Strong verbal and written communication skills.
Excellent listening and decision making skills.
Well-organized, detail oriented professional and ability to prioritize and make decisions.
Highly self-motivated; able to lead initiatives with authority.

Apply via :

www.roche.com

October 28, 2024