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Regulatory and / or Organisational Requirements:
Functional lead and/or project manager of local/regional trial team members and colleagues including but not limited to:
Job Expertise
Required Capabilities (Skills, Experience, Competencies)
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Duties & Responsibilities
STRATEGY
DRIVING BUSINESS RESULTS
A. INPUT TO BUSINESS PLANNING CYCLE (OUTLOOK AND LONG TERM FORECAST (LTF) PROCESS)
B. BUSINESS PERFORMANCE
PROCESS/CROSS-FUNCTIONAL COLLABORATION
A. INTEGRATED BRAND & CUSTOMER PLAN (IBP/ICP) DEVELOPMENT
B. OPERATIONAL PLAN EXECUTION/IN-MARKET IMPLEMENTATION DRIVE
C. LAUNCH READINESS
D. CROSS FUNCTIONAL ALIGNMENT IN BRAND TEAM AND TA INTERACTION WITH OPU AND GLOBAL
E. MONITORING AND REPORTING
F. SUPPORT TO Go-To-Market (GTM) TRANSFORMATION
PEOPLE
Requirements
- Business and Marketing Acumen
- Patient Centricity
- Customer Orientation
- Strategy Development
- Project Management
- Effective Execution
- Relationship Management
- Proficiency in MS Office, Outlook and database application
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This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Oncology therapeutic area (TA).
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The Position:
This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Jardiance T2D & Obesity therapeutic areas (TA).
Duties & Responsibilities:
Requirements:
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The Position
An opportunity to lead the scientific content management from end-to-end process for creating, planning, tagging, and communicating in multi-channel customer communication platforms. Work in a cross-functional environment and act as project leader for medical campaign dashboard, multi-channel engagement, and explore innovation in contents and actionable insights.
Duties & Responsibilities
Requirements
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The Position:
This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Jardiance T2D & Obesity therapeutic areas (TA).
Duties & Responsibilities:
Requirements:
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Description
The TA Franchise Head for Specialty Care (Interstitial Lung Disease/Respiratory, Oncology/Immunology, Mental & Retinal Health) will be responsible for the successful translation of global to local strategy, preparation of pipeline assets' launch across region and driving commercialization of the Franchise portfolio by developing overarching integrated cross-functional strategies and ensuring excellent execution.
Has oversight of the whole TA Franchise Team in ROPU Centre, directly lead the commercial team (i.e. marketing) and provide strategic leadership to the cross-functional franchise team (e.g. MAHA, GTM, Medical Affairs). Together with functional leadership, design the overall Franchise Strategy across TAs under the franchise at regional level, to guarantee that the different TAs and brands have the right strategy, overall planning, and adequate resources to set and achieve ambitious results. Ensure overall launch preparation for new assets.
Guide OPU TA Franchise Head of Specialty Care (SpC) in the implementation of ROPU Strategies in respective TAs. Drive the Specialty Care Marketing and Sales/FF organization across ASKAN, to develop the Integrated Customer Plans (ICPs) built on solid customer and patient insights, meaningful to ASKAN region. Drive the local / OPU commercial organization to deliver results according to established internal/external targets and KPIs. Provide regional guidance to OPUs on Go-To-Market strategy and respective customer engagement models for for SpC TAs and assets, in alignment with the ROPU Centre GTM and OPUs.
Duties & Responsibilities
Requirements
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The Position:
This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Lung Portfolio.
Duties & Responsibilities:
Requirements:
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The Position
Tasks & Responsibilities
1. Regulatory Planning and Submission Strategy
2. Quality and Compliance
3. Operational Excellence
Requirements
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Description
1. Contribute to the establishment, continuous improvement and maintenance of the Quality Management System (QMS) in ROPU ASKAN by ensuring that all external (e.g. GMP, GDP, GDPMD, GSP, GIP) and internal BI requirements (e.g. Policies, OCS, OCP, ACP) are implemented at ROPU and each OPU, monitored for performance/adherence and improved, if required.
2. Support OPU Commercial Quality (CQ) Managers/Leads, Specialists, Associates and LPCOs) in executing key defined steps in relevant quality processes where such activities are centralized at ROPU.
3. Support the Commercial Quality Strategy for the ROPU together with the Head of Commercial Quality ROPU ASKAN and respective Corporate and ROPU Management.
4. Support the Head of Commercial Quality ROPU ASKAN and Commercial Quality Manager ROPU ASKAN and DMS/LMS Specialist ROPU ASKAN in ensuring appropriate Quality oversight related to GMP and GDP/GDPMD/GSP/GIP in the ROPU including:
• Management of external service providers in all quality relevant aspects during the life cycle of a contract beginning with issuance until termination to ensure local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines.
• Performing GMP/GDP/GDPMD/GSP/GIP audits at suppliers and external partners (qualification and regular audit), including follow-up of CAPAs at 3rd parties.
• Implementing/revising relevant GMP/GDP/GDPMD/GSP/GIP quality systems related to commercial product supply in the ROPU to meet the continual needs of the company and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.
• Knowledge management within ROPU by supporting best practice sharing and ensuring training across the ROPU.
• Efficient implementation of standards within the ROPU by maintaining a common document management system; implementation of OCS, OCPs and further Corporate documents; monitor rollout and by standardization of processes.
• Continual quality and compliance improvement within ROPU by identifying optimization potentials and by monitoring OPU performance via self -inspection/self-assessment program.
• Assume role as ROPU system owner (Local MSO), SME, administrator and key user for relevant Quality Systems (E.g.Investigation, CAPA, change control, and product complaints etc).
5. Support the maintenance of trainings within the electronic training system and management of controlled documents in the electronic document management system for all Business unites, functions, departments and countries within ROPU ASKAN.
6. Support to ensure proper implementation of global procedures related to training and document management for ASKAN and continuous improvement of training and document management system in ROPU ASKAN.
7. Provide support to management/execution of OPU Commercial Quality operation/activties (as needed).
8. Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).
9. Provide commercial quality input/support to certain business initiatives, projects, requests as per requirements and established timelines as needed.
10. Take on and/or support any other tasks assigned.
Duties & Responsibilities
• As Local MSO, SME, administrator and key user for Quality System Management and/or supporting:
- Creation and maintenance of relevant quality system for regional/local SOPs/Working Instructions (e.g. write, review, approve, periodic review etc);
- Ensuring that applicable Corporate Procedures are transferred into ROPU or local SOPs/Working Instructions
- Ensuring that training on relevant Quality SOPs/Working Instructions are properly performed and documented before implementation.
- Ensure system records are tracked, updated and closed as per established requirements/timelines.
- Ensure system KPIs are tracked, reported and met as per established requirements/timelines.
- Analyze any significant changes in the GMP/GDP/GDPMD/GSP/GIP environment and identify need for SOP/Working Instructions writing and/or communication to Corporate Quality (Operations Regulatory Intelligence “ORI”).
• Provide to other local MSO, SME, Administrator, and key users for Quality System Management on above activities if needed.
• Provide support to management/execution of OPU Commercial Quality operations/activities (as needed).
• Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).
• Present process evaluations and implement agreed changes for continuous improvements to the ROPU Quality Systems and Quality Manual.
• Represent ROPU ASKAN Commercial Quality and act as an interface to Global Corporate/Global Quality Organization; give feedback to Corporate/Global level quality initiatives and take actions to ROPU/OPU levels.
• Represent ROPU ASKAN Commercial Quality team or Head of Commercial Quality ROPU ASKAN to provide input/support for certain business initiatives, projects, requests, matters as per relevant requirements and established timelines as needed.
• Provides consistent global, regional and local business support for LMS through:
- Coordinating global, regional and local assignment process.
- Providing technical expertise (system troubleshooting, advice and assistance to Learners, Curriculum Owners, Line Managers, etc.).
- Promoting best practices in the utilization of LMS.
- Supporting the globally defined training process within ROPU ASKAN.
- Supports the maintenance and development of the regional training process, including active support for the MTGC (Mandatory Training Governance Council), and creation and execution of related procedures, guidelines and decisions.
- Support global, regional and local curriculum owners in the creation and maintenance of curricula, and the assignment of curricula to intended learners in a timely and structured manner.
- Ensure training assignment of regional and local training in a coordinated manner, and within the given timelines according to the globally defined processes.
- Ensure a comprehensive tracking of all learning, both e-learning as well as group and face to face learning.
- Provide support during audits and inspections in case of questions regarding training and document management.
- Carefully track and report training and document management KPIs, and set activities for improvement of KPIs as needed.
- Support knowledge exchange and best practice sharing regarding LMS, within ASKAN as well as global BI network.
- Be the Deputy Process owner for the processes of Training and Document Management in ROPU ASKAN.
- Be the back-up to assume the role & responsibilities of DMS & LMS Specialist, ROPU ASKAN role when needed.
• Provide support as needed to ensure lean and appropriate SOP development within ROPU ASKAN.
• Establishing a system to support authors of controlled documents, in creation, maintenance/update as well as learning assignment to target audience.
LMS continual improvement:
• Provide support for the further development and maintenance of the training and document management systems and processes within the globally provided framework.
• Initiate efforts for effective and efficient system use.
• Act as technical and business expert in the use of LMS and maintain system quality, report on standard system metrics, support MTCG periodic curriculum review.
Requirements
· Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or related science diploma with relevant work experience.
· 5-7 years Quality experience in pharmaceutical or biologics or medical devices MNC. Any GMP quality experience is a plus.
· Minimum 5 years experience in country/regional commercial quality operation/activities management and execution in pharmaceutical or biologics or medical devices MNC. Any regional commercial quality experience is a plus.
· Sound and direct experience/knowledge (2-4 years) in training management and controlled document management system and using electronic system for training and controlled document management.
· Thorough knowledge of GDP quality/regulatory requirements with practical expertise in commercial quality operation/activities in pharmaceutical/vaccines/medical devices industry.
· Works well in both a team-orientated environment and independently
· Attention to detail, good organizational skills, flexibility
· Sense for urgency and efficiency
· Demonstrates ability to manage multiple activities
· Excellent oral and written communication skills in English language
· Communicates effectively results and project status both internally and externally
· Prepares technical reports including executive summaries and management presentations
· Demonstrates strong analytical skills, is able to judge when more information is needed, where to obtain it and to draw sound conclusions from available information
· Demonstrates mature judgment and strong decision-making skills regarding project and product issues
· Is able to deal with complexity (critical thinker)
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DUTIES & RESPONSIBILITIES
REQUIREMENTS
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Task & Responsibilities
· Accountable for IT Global Application Experience provided services for the area under scope (group of applications/software, product team, region)
· Ensures the operational quality/performance of the service according to defined SLAs. Correct provisioning of the services, its capacity, stability, operational excellence performance, vendor operational management and continuous improvement actions
· Accountable for the global IT Support Services for the assigned system cluster - support will be provided by one of our IT Support vendors
· Overall view of the service and analysis of trending and deviations of support
· Ensure the correct quality/performance of the service according to Service Level Agreement
· Coordinate the workload of support team, responsible for the vendor operational management
· Assure knowledge within the team and look for service improvements
· Serve as the point of escalation for major incidents relating to the support service
· Responsible of ensuring resource efficiency, scalability of the service and implementation of simplification measures, such as automation, "shift left" actions, etc.
· Regular proactive review of support tickets to assure service quality according to SLA
· Execution of defined meetings with different stakeholders (business key users, IT functions and external support teams)
· Ensure proper onboarding of new applications to the support service
Experience
· Minimum 5 years of experience in IT Application Operational Support or System Analyst roles
· Minimum 3 years of experience in managing IT Support vendors preferred
Skills/Requirements
· Bachelor’s degree or relevant IT work experience
· SalesForce.com / Veeva: 3 to 5 years of support experiences in global multiple country setup
· Service Management Coordination, experience with Services Management processes and demonstrated coordination
· Stakeholder Management
· GxP Knowledge (if applicable)
· Operational Vendor Management (if applicable)
· Strong organizational skills
· Strong client support/customer service skills
· Strong global relationships and communication skills with Business colleagues and IT colleagues
· Ability to prioritize when working on multiple tasks to ensure timely delivery
· Strong troubleshooting skills
Language
· English language: Advanced Reading & Writing skills, ability to communicate with global teams
· Additional languages are welcome (ie: Chinese, Japanese)
Technical Skills
· IT Service Management tools (ticketing) tool user knowledge
· ITIL v4 knowledge – advanced in Incident and Problem Management processes
· MS365 applications usage (advanced user in PowerPoint, Word), PowerBI, Flow
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If you don't have a Malaysian citizenship, but are living in Malaysia or if you are planning to move to Malaysia and are looking for jobs that can sponsor you, it is up to each individual employer on how it handles international candidates. We encourage you to read our blog post to help provide more information: 7 Easy Steps to Find Jobs in Malaysia As A Foreigner.
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There are 6 position levels and each level can be associated with a salary range and different types of job titles. Jobs levels can be categorised into: non-executive, fresh/entry level, junior executive, senior executive, manager and senior manager.
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