Total 4 job vacancies by A. Menarini Asia-pacific Pte. Ltd.

POSITION SUMMARY:

This role is responsible for building and maintaining a robust data foundation to drive commercial growth, operational excellence, and data consolidation within the region. Reporting to the Senior Lead, Data & Analytics and collaborating closely with the Corporate team, you will be instrumental in designing, developing, and implementing data pipelines, data models, and AI algorithms to optimize commercial performance, improve forecasting, enhance supply chain visibility, and reduce data redundancy.

The overarching objective is to transform data into actionable insights to drive business growth and efficiency. You will work closely with cross-functional teams across the region to establish and streamline data processes, ensuring data quality and consistency. Your role will involve managing and optimizing diverse data sources, including sales, marketing, supply chain, finance, customer, and operational data, to derive actionable insights for business decision-making. By harnessing the power of data and AI, you will contribute to defining the future of customer experience and driving overall business success.

KEY RESPONSIBILITIES:

• Design, develop, and maintain efficient data pipelines to extract, transform, and load data from various sources, including ERP, CRM, supply chain systems, third-party platforms, e-commerce platforms (via APIs), and omnichannel engagement platforms into a centralized data warehouse and on-premise systems.
• Identify opportunities to consolidate data sources and reduce redundant data subscriptions, including from omnichannel engagement platforms.
• Develop and maintain a data catalogue to improve data accessibility for commercial teams and enhance data-driven insights from omnichannel customer journeys.
• Create and manage master data related to products, customers, suppliers, inventory, and third-party data to ensure data consistency and accuracy for commercial analysis and data consolidation efforts, including data from omnichannel engagement platforms.
• Develop and implement data models to support sales forecasting, customer segmentation, pricing optimization, and other commercial initiatives while aligning with the company's data consolidation strategy and leveraging data from omnichannel engagement platforms.
• Build and maintain a scalable and secure data infrastructure to accommodate increasing data volumes and variety to support commercial growth, data centralization, and integration of omnichannel engagement data across both cloud and on-premise environments.
• Collaborate with commercial teams and other departments to identify data-driven opportunities, including leveraging third-party data insights and data from omnichannel engagement platforms, and translate business requirements into actionable data solutions that contribute to data consolidation.
• Develop and implement a strategy to create a unique customer identifier across all omnichannel touchpoints.
• Identify and prioritize new data sources within the region, including data from emerging omnichannel engagement platforms, to enhance commercial intelligence and support business growth while considering opportunities for data consolidation and cost reduction.
• Conduct exploratory data analysis, including analysis of third-party data and data from omnichannel engagement platforms, to identify patterns and trends that can drive revenue growth, improve profitability, and inform data consolidation efforts.
• Ensure data quality and integrity, including validation of third-party data and data from omnichannel engagement platforms, through data profiling and cleansing to support accurate commercial reporting and data consolidation initiatives.
• Optimize data pipelines and query performance to handle diverse data sources, including data from omnichannel engagement platforms, efficiently and enable timely commercial insights while maximizing data utilization across both cloud and on-premise environments.
• Provide technical support to commercial teams and data analysts in utilizing data-driven insights, including those from omnichannel engagement platforms, to improve business performance and contribute to data consolidation goals.
• Collaborate with the Corporate team on data strategy, standards, and best practices to align regional data initiatives with overall commercial objectives, data consolidation efforts, and the effective utilization of omnichannel engagement data.
• Design, develop, and deploy AI models on-premise to address data privacy and security concerns.
• Manage data governance and compliance requirements for both cloud and on-premise data environments.

KEY REQUIREMENTS:

• Bachelor's degree in Computer Science, Statistics, Mathematics, or a related field.
• At least 3 years of experience in data engineering, including data ingestion, transformation, and modeling, with a focus on integrating diverse data sources across cloud and on-premise environments. Experience with pharmaceutical industry data and regulations is a plus.
• Strong proficiency in SQL and data warehousing concepts for both cloud and on-premise platforms.
• Experience with Python for data manipulation and analysis, including API integration and model development.
• Experience with on-premise data management and security best practices.
• Understanding of cloud-based data platforms (e.g., AWS, GCP, Azure) and on-premise data infrastructure. Experience in Google Cloud Platform is preferred.
• Knowledge of supply chain management principles and processes is preferred.
• Able to process datasets in Mandarin language, and to interact and work closely with Mandarin- speaking stakeholders.
• An innovative mindset combined with an agile way of working and adaptability to a fast-paced environment.
• Strong analytical and problem-solving skills.
• Strong documentation skills.
• Excellent communication and interpersonal skills - Ability to communicate with both technical and business teams.
• Strong time management and organizational skills - Ability to manage multiple projects and prioritize tasks.
• Attention to detail and accuracy.
• Ability to work effectively both independently and as part of a team - Ability to work cross-functionally and across local markets within APAC region.
• Able to commit for 1 year contract.

POSITION SUMMARY:

As part of the Regional Medical Affairs Team, the Regional Medical Affairs Manager will act as the regional therapeutic expert for our Consumer Health, Pain and CNS portfolios (subject to be updated as for business and medical needs). This role will also be responsible for clinical operations, real world evidence such as CRO management, clinical trial documents and clinical operation support to affiliates. In addition, this role will support on medical operation and compliance activities (RMA audits, digital initiatives, SOP knowledge).

KEY RESPONSIBILITIES:

Medical Affairs

• Provide medical and scientific support.
• Act as the regional therapeutic expert for assigned therapeutic areas. Provide Medical affairs support to local affiliates where there is no medical presence as required.
• Work in collaboration with the regional marketing teams and provide strategic medical input into core brand strategies and support medical marketing activities such as promotional material, product launches, omnichannel engagement, brand planning, etc.
• Perform medical assessment for the respective brands for business development opportunities as well as other assets as assigned
• The regional medical point of contact for the TAs for the regional and local medical and marketing teams for providing directions and support on medical action items, including but not limited to KOL engagements, insight seeking, advisory boards, Medical led meetings and initiatives, patient centricity, medical omnichannel communications, etc.
• Manage medical information inquiries for the assigned therapeutic area.
• Conduct regional scientific training on the disease and products.
• Lead life cycle management and data generation activities for the regional/corporate brands.
• Support the building of strong regional advocates and expert panels and speakers for the brands.
• Maintain knowledge of relevant regulations and guidelines and disseminate same to clinical project teams.
• Research and prepare training on therapeutic areas and indications of relevance and maintain an awareness of trends and changes of importance in the management of those indications.
• Initiates and maintains interactions with key opinion leaders and investigators in therapeutic areas of interest. Create and implement KOL mapping and engagement plan.
• Attend and act as an advisor to relevant clinical development projects or clinical meetings.
• Create or support the development of medical/scientific materials and slide decks as needed and ensure the content is reviewed and approved.
• Act as backup for pharmacovigilance case assessment as needed. Work together with the Pharmacovigilance team to perform adverse event causality assessment for local, regional and global products as well as partner products

Clinical Operations:

• Leads all stages of the clinical study development process including: feasibility assessments; protocol design; CRF design; ISF investigational site selection; generation of clinical study reports and the development of study-related documents, informed consent documents, study manuals and plans, trial master files (TMF), case report form design, etc. Identify data gaps and the need for phase 4 RWE studies for data generation.
• Provide clinical operation support to the local team as needed.
• Act as regional medical lead for CRO management, conduct due diligence for onboarding of the CRO and participate in CRO qualification and audit process.
• Work closely with CRO and keep track of project timeline, budget and milestones.
• Takes responsibility for and initiates the review of all clinical study documents and reports such as project management plans, data management plans, interim reports, etc.
• Work closely with the regional medical director/associate director to study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
• Proactively identifies and resolves issues, and participates in process improvement initiatives as required.
• Reviews and approves invoices from study vendors, investigators, consultants, etc. and planning of the clinical study budgets.
• Oversee medical aspects of the risk management and risk mitigation strategies.
• Act as data manager to ensure the correctness of the clinical study data and verify the statistical analysis.
• Present clinical study data at regional and global conferences as a poster or oral presentation.
• Work with regional TA lead, regional marketing team, local medical team, and local marketing team on the dissemination of the clinical study data; participate/organize investigator meetings, steering committee meetings, and interdepartmental meetings.
• Ensures GCP, regulatory compliance, internal SOPs and working instructions are maintained throughout the clinical study lifecycle.

KEY REQUIREMENTS:

• At least 5 years of medical affairs and clinical research/development experience within a pharmaceutical or Biotechnology Company.
• A certified Doctor (MBBS, MD) or a post-graduate scientific degree in medicine, biology, PhD, etc. will be an advantage.
• Solid understanding of medical affairs in the pharmaceutical industry with the ability to connect medical affairs and commercial priorities to work with cross-functional stakeholders as well as experience in people management and project-based activity and successful delivery of initiatives are required.
• Excellent written and verbal communication skills and good presentation skills.
• Travel to markets within APAC would be required.
• Strong Commercial awareness - Ability to work with regional and local commercial stakeholders.
• Unquestionable integrity and positive attitude.
• Great at building relationships, particularly with KOLs.
• Willing and capable of managing multiple projects, tight timelines and responsibilities.

POSITION SUMMARY:

The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.

KEY RESPONSIBILITIES:

• Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand and in new frontier markets e.g. Maldives, Sri Lanka, etc.
• Regional Lead in change management and compliance in APAC regions
• Regional Lead in line extension projects to serve commercial marketing needs
• Assess regulatory viability of bringing EU-approved products with local regulatory colleagues through understanding the quality, non-clinical and clinical data of the products to meet country- specific requirements
• Provide solutions to overcome regulatory hurdles, reduce inventory risk and also shorten dossier preparation time so to achieve speed to market
• Artwork approver of APAC common-pack and specific-pack artworks with knowledge of labelling requirements in individual countries
• Propose best recourse of action to meet compliance requirements for legacy non-compliance issues
• Able to represent regulatory affairs in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
• Develop relationships with various partners’ regulatory function stakeholders: product owners, manufacturers, distributors, external consultants
• Maintain relevant databases for registrations and status as required
• Other ad-hoc duties requested time from time from superior/cross-functional colleagues

KNOWLEDGE/ QUALIFICATIONS / SKILLS / EXPERIENCE:

• Candidate must possess at least a degree in Pharmacy/Pharmaceutical Sciences
• At least 1 year of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations
• Attention to details
• Ability to collaborate and work at a fast pace inmultidisciplinary matrix organisations. Easily adapts to IT systems to help facilitate work processes

POSITION SUMMARY:

Being part of the Regional Medical Affairs Team, this role will directly report to the Associate Regional Medical Director, based in Singapore. This role will be act as the Therapeutic Area Regional Medical Lead (MPH and MCH portfolio), be responsible for medical governance, RMA audits, SOP updates, medical compliance, digital initiatives and clinical operations matters.

KEY RESPONSIBILITIES:

Medical Affairs: Provide medical and scientific support for the therapeutic areas

• The regional therapeutic expert for the assigned therapy areas (TAs), working in collaboration with the regional marketing teams.
• Provide strategic medical input into core brand strategies and support medical marketing activities such as promotional material, business development assessments, product launches, omni channel engagement, brand planning etc.
• The regional medical point of contact for the TAs for the regional and local medical and marketing teams for providing directions and support on medical action items, including but not limited to KOL engagements, insight seeking, advisory boards, Medical led meetings and initiatives, patient centricity, medical omni-channel communications etc.
• Conduct regional scientific trainings on the disease and products
• Lead life cycle management and data generation activities for the regional/corporate brands
• Support building of strong regional advocates and expert panels and speakers for the brands.
• Maintain knowledge of relevant regulations and guidelines and disseminates same to clinical project teams
• Research and prepare training on therapeutic areas and indications of relevance and maintains an awareness of trends and changes of importance in management of those indications
• Initiates and maintains interactions with key opinion leaders and investigators in therapeutic areas of interest. Create and implement KOL mapping and engagement plan.
• Attend and act as advisor to relevant clinical development projects or Menarini Clinical meetings
• Conduct medical assessment for the respective brands for business development opportunities

Medical Governance, RMA audits, SOP updates, Medical compliance, digital initiatives

Clinical Operations :

• Leads all stages of the clinical trial development process including: feasibility assessments; protocol design; CRF design; investigational site selection; generation of clinical study reports and the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
• Regional medical lead for CRO management
• Takes responsibility for and initiates the medical review of all clinical study documents and reports
• Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
• Proactively identifies and resolves issues, and participates in process improvement initiatives as required
• Reviews and approves invoices from study vendors, investigators, consultants, etc. and planning of the clinical study budgets.
• Oversee medical aspects of the risk management and risk mitigation strategies
• Ensures GCP, regulatory compliance, internal SOPs and Working Instructions is maintained throughout the clinical trial lifecycle

KEY REQUIREMENTS:

• Bachelors or post graduate medical qualifications
• Ideally qualified with Diploma in Pharmaceutical Medicine and/or Diploma in Human Pharmacology
• At least 3 or more years of medical affairs and clinical research/development experience within a pharmaceutical or biotechnology company
• Comprehensive knowledge of the clinical development process and its critical paths
• Good command of spoken and written English ability
• Excellent written and verbal communication skills and good presentation skills
• Travel to markets within APAC would be required
• Commercial awareness
• Unquestionable integrity and positive attitude
• Great at building relationships, particularly with KOLs
• Willing and capable to manage multiple projects, tight timelines and responsibilities