Jobs at AstraZeneca

What you’ll do?

You will help the business determine competitive pricing strategies and develop effective forecast models based on trends and demand patterns. The successful candidate will report to the Pricing and Tender Manager and have the responsibility for creating and developing current and accurate pricing strategies, maintain forecast models for distributors, incorporating business intelligence and forecast information gathered from sales, marketing, finance and other data sources. You will also work closely with the Demand Planning and Supply function across SSA to ensure optimal product availability across all markets in SSA.

Some areas of focus for this role will include:

• Assists in implementing pricing strategies and rebate programs
• Assists with analysis of pricing strategies to support the development of pricing policies and innovative contracting schemes
• Assists in development, programming and operation of new database systems to support sales and marketing strategies for new accounts / tenders
• Assisting in producing quality tender submissions by ensuring the correct documents are collected
• Updating the tender records and maintaining the filing system
• Following up on tenders submitted
• Collecting and Compiling the required tender documents and quotes by coordinating input from various departments
• Assisting in collating a detailed monthly report
• Developing and maintaining a strong working relationship with internal and external stakeholders
• Assist with the volume and value forecast process to drive a reliable and realistic forecast
• Supporting the S&OP process to drive forecast accuracy optimization in line with supply capabilities
• Support the Integrating Business Planning (IBP) monthly discipline with analytics and close cross functional collaboration
• Keep track of ongoing tenders with demand planning in mind, to ensure supply is aligned to support such tenders
• Monitor and drive discussions around inventory health of distributors, making recommendations of orders to be placed or postponed in line with targeted cover strategy.
• Facilitate expired inventory write off and liquidation whenever required in line with the company principals and ensure minimal impact on P&L and product reputation in the market
• Assisting with the import process into the Sub-Saharan Africa countries in line with the regulatory requirements and collaborate with regulatory team to ensure appropriate licenses are in place for non-registered products.
• Assist with the operational performance of the outsourced LSP to ensure on-time and cost-efficient movement of products to customers. Includes the management of letters of credit requirements for some key markets.
• Other related assigned related task and projects.
• Ensures compliance processes related to tender submissions and distributor processes
• Ensures compliance processes related to tender submissions and distributor processes

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

• Bachelor’s degree in relevant field (Marketing, Science, Economics or Finance)
• Strong analytical skills
• Working knowledge of Pricing Strategy and Managed Care impact

Desirable for the role

• Masters degree
• Financial modelling and/or analytics
• Familiarity with operating in Global business

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As MSL in SSA Respiratory team, you will be presented with a canvas on which to draw your Picasso of a revolutionized healthcare system that is centered around the patients to ensure the best possible outcomes.

This is a field based role that provides medical and clinical expertise in priority therapeutic areas and builds AZ scientific leadership. The role focuses on the development of professional relationships with Key External Experts (KEEs), building deep scientific understanding of AZ compounds by engaging KEEs in clinical research, ESRs, scientific exchange meetings and advisory board meetings.

In addition, the MSL will input into Brand Strategy and Life Cycle Management (LCM) and implementation of medical activities aligned with brand strategy. Further accountabilities include delivery of medical education and clinical support to Health Care Professionals (HCPs) and training of sales teams.

Typical accountabilities will include:

External Medical & Scientific Engagement

Build, enhance and maintain the engagement with scientific leaders (KEEs)

• 75% of time in field engaging HCPs and external stakeholders across territory and brands.
• Proactively identify HCPs with high levels of scientific expertise in local treatment practice to collaborate on specific medico-marketing activities.
• Develop and implement Key External Expert (KEE) engagement plan in collaboration with TA lead.
• Develop KEE database, provide recommendations for advisory board participation & potential speakers and train speakers as appropriate.
• Develop own scientific knowledge and share emerging data with HCPs, discussing all aspects of the data in a scientific, objective, and balanced way.
• Communicate results of studies completed to HCPs by translating their clinical value and ensure proper incorporation into business strategies.
• Respond to unsolicited requests for information about unapproved AZ products or unapproved uses of approved products by presenting such information in an objective, scientifically balanced, substantiated manner.​

Develop or initiate scientific programs to explore unmet medical needs in priority disease areas 

• Interact in the field with KEEs on clinical trials, ESRs and discuss potential involvement in ESR and RWEs
• Take an active role during the implementation of clinical research activities, selection of investigators and maintain relations with them, coordinated by the TA lead / Medical Manager, within the framework of clinical study plans (Investigator meetings, initiation visits and protocol training)
• Coordinate the submission to journals of clinical research results to be published as posters, abstracts, full text or manuscripts and the review of the results by the global review board.

Medical & Scientific Support for Internal Stakeholders

Establish AstraZeneca as a scientific leader through proactive, updated, and effective medical input

• Provide AZ internal stakeholders with an understanding of the local medical community, clinical practice, trends and real or perceived gaps in current scientific knowledge and medical treatment, competitive intelligence
• Provide medical input for development of brand plans
• Develop and implement the local medical plan to address unmet medical needs and ensure alignment with the brand plan
• Develop and implement pre-launch medical plan & activities for new products at least 2 years prior to the planned launch to address key clinical and scientific challenges
• Provide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needs.
• Supports the Training MSL lead in the Annual training plan, priorities for general group and individual program.
• As the Medical Market Access (MA) Lead to provide MA team with insights from the KEEs, and support for dossier preparation and any other activities that support the Market Access function.

Governance and ensuring overall adherence to processes and regulation [include but not limited to patient safety, clinical trials, promotional activities]

• Ensure compliance with AZ code of conduct, Corporate Governance, Audit requirement, guidelines, codes, policies, and procedures.
• Provide medical input to the creation, development and agreement of promotional material and ensure all material is in line with internal SOPs.
• Ensure confidentiality is maintained (i.e., intellectual property, product, strategy, and salary information).
• Disclose potential breach of codes or conducts.
• Plan actions to be taken regarding drug safety notices and quality issues raised by the local headquarters or AZ global, prepare communication documents and follow up & document related trainings.
• Convey feedback obtained from physicians regarding drug safety to Drug Safety Manager and conduct necessary follow-up.

Development

• Continuously demonstrates development of scientific expertise in disease area(s) and personal skills
• Actively participates in AZ trainings, projects and meetings depending on development needs
• Shows positive engagement and response to coaching and feedback received from line manager
• In daily work takes time to reflect on customer interactions and works on priorities for development as agreed with line manager 
• Develops behaviors and skills leading to enhanced effectiveness as outlined in competency definitions
• Proactively demonstrates the AZ Values

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential:

• Bachelor's Degree in Science.
• Qualified Medical Doctor.
• Medical/Scientific knowledge in the responsible disease area.
• Experience in relationship and stakeholder management.
• Project management experience.

Desirable:

• Understanding of multiple aspects of Medical Affairs.
• Knowledge of the latest technical and regulatory developments.

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What you’ll do?

As the successful candidate, you will have an opportunity to work with a passionate team of individuals dedicated to accelerating access to life-changing & innovative medicines for our patients. In addition, gain exposure and network to Health Authority regulatory framework across the various SSA countries within the African Cluster. Prepare regulatory tactical submission plans for allocated project/products that implements the agreed regulatory strategy to develop and maintain products. Provides independent tactical/scientifically related guidance cross functional on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.

You will act as Qualified Person Responsible for Pharmacovigilance (QPPV) and ensure compliance with both AstraZeneca requirements and global and local regulatory requirements for patient safety. You will also be responsible for managing skill development and performance management of your direct reports and resource allocation.

Typical accountabilities will include:

REGISTRATION PLANNING AND BUSINESS SUPPORT

Implement registration plans and provide support to Commercial.

• Implement the registration business plan for regulatory affairs that reflects the business objectives of the SSA MC and aligns with brand marketing strategies to deliver business critical regulatory needs within agreed timelines.
• Provide regular feedback to Head of Regulatory Affairs, marketing, and sales teams on the regulatory submission progress of specific products and ensure that all teams have up to date regulatory information and support needed to drive performance in their respective departments.
• Proactively identify issues and manage risk taking appropriate action as required on regulatory submission in collaboration with Regulatory Affairs manager and identify and drive ongoing improvements.

GOOD REGULATORY PRACTICE (GRP)

• To implement GRP standards in the SSA Hub in line with International Procedure 1-P56-cv-X "Good Regulatory Practice in AstraZeneca" that support license to operate across the Regulatory Value Chain.
• Implement GRP standards in the following process areas:
  • Marketing Authorization Applications.
  • License maintenance.
  • Pharmacovigilance.
  • Submission’s compilation and dispatch.
  • Management of Regulatory Knowledge (including Regulatory Product Knowledge and Regulatory Status Information).
  • Health Authority interactions.

Ensure an "inspection-ready" Quality System, providing evidence that there are mechanisms in place to ensure that license to operate regulatory activities are being met in accordance with legislation and AZ GRP procedures.

•  To track and manage all GRP activities and report any non-compliances to the GRP lead.
•  To ensure that all local SOPs and checklists are updated in line with global SOPs.
•  To monitor GRP progress and initiate improvement plans for the SSA Hub QMS.
•  Complete training in line with the Saba Cloud training matrix relevant to job profile.

REGULATORY PROCESS FOR ALLOCATED PRODUCTS/MARKETS

• Ensure that the regulatory processes for allocated markets/products are performed timeously in line with GRP.

Marketing Authorization Applications:

Submit Marketing Authorization

• Applications to Health Authorities according to SSA HA guidelines and GRP, in the shortest possible time based on business priorities.

License maintenance:

• Ensure all post approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved.
• Ensure all License Renewals are submitted on time, prior to license expiry or in accordance with the planned submission date.

Pharmacovigilance:

• Ensure individual PBRERs (where required) are submitted to Health Authorities timeously.

Submissions compilation and dispatch:

• Assess registration documents for adequacy of information.
• Obtain relevant information from Global.
• RA and resolve queries as they arise to ensure delivery of submissions within agreed timelines.

 Health Authority interactions:

• All communication with Health.
• Authorities regarding submissions, product registration or maintenance throughout the lifecycle of the product is managed effectively via the SSA in-market contact/distributors.

ESTABLISHED STAKEHOLDER RELATIONSHIPS AND CONSOLIDATED REGULATORY ROLE

• Develop and maintain relationships with key internal and external customers and maintain visibility and accessibility, working in close collaboration with them to realize AZ objectives.

Build and maintain relationships with Health Authorities to influence regulatory timelines and outcomes

• Communicate regularly with SSA MC colleagues regarding regulatory requirements and objectives and share best practice ideas.
• Represent AZ to key players and other identified stakeholders.
• Attend local trade association meetings to network with other Pharmaceutical Companies for updates to regulatory requirements and best practices across SSA.

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential

• Bachelor’s Degree in Pharmacy. Advanced degree a plus.
• Valid and available Annual Practice License for the Pharmacist.
• Registered with Pharmacy and Poisons Board.
• Significant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authority.
• Project and process management.

Desirable

• Drives Performance – holds others accountable to high standards and clarifies what needs to be done and the consequences for the individual and/or the organization.
• Works collaboratively – respects and integrates diverse views into decisions/proposals.
• Problem solving