Experience:

3 years required

Skills:

Compliance, Purchasing, GMP, Thai, English

Job type:

Full-time

• Provides quality support for acquisition and divestiture activities, including change control.
• Adverse event and/or Health Authority reporting.
• Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure.
• Audit Readiness, including Inspection management:
• Ensures compliance and audit-readiness of site to J&J Quality Policy Standards and applicable local regulatory requirements.
• Lead as site SME for inspection management by coordinating activities related to pre- and post- audit including providing briefing and guidance to all cross functional team, managing audit arrangement and lead in audit response to auditor.
• Change Control.
• Lead for site's change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken. Monitors related metrics and initiates actions for improvement.
• Complaints management.
• Lead the end-to-end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends, related metrics and initiates actions for improvement.
• Document control.
• Support and ensure site compliance to document lifecycle management.
• Labeling and Packaging.
• Provides Quality support (such as updating quality agreements, issuing redressing instructions) in repack/relabel operation to ensure compliance to internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.
• NC CAPA Management.
• Lead for site's NC/CAPA management. Responsible to ensure process is followed and records are managed in a timely manner with proper investigation, root cause analysis and corrective and preventive action taken. Monitors related metrics and initiates actions for improvement.
• New Product Introduction and Product Discontinuation.
• To provide Quality support during new product launch and establish any new quality processes to support commercial launch if applicable.
• Escalation and Field actions.
• Oversee the management of Escalations, Field Action, Mock Field Action and Stop shipment applicable to the site.
• Product Release and Product Returns.
• Supports activities related to product inspection and release, temperature excursions and trade returns according to product specifications and internal procedures.
• Purchasing Control, including POLO.
• Support activities related to purchasing controls. Ensures suppliers/POLO are appropriately qualified, monitored and in compliance to up-to-date Quality Agreements, where applicable.
• QSMR and metrics reporting.
• Coordinates key quality metrics reporting. This includes Non-conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines.
• Quality Manual.
• Responsible to establish and maintain site's Quality Manual.
• Records retention.
• Provide guidance to LOCs on record retention process in collaboration with records coordinator.
• Training Management.
• Support and ensure site compliance to GxP training plan for quality system elements covered by the site's quality manual. This role is also responsible for the metrics, communications, reports and non-conformance related to these areas.
• 3PL and Distributor quality oversight.
• This role is responsible for the execution and compliance of Quality Management Systems elements applicable to the 3PL and Distributor as required per J&J standards and applicable local regulatory regulation, including: product release and returns, handling of storage, temperature controls, traceability, repack relabels, loaner set management, and NC/CAPAs. 2. This role is also responsible for purchasing control activities related to the distributor such as qualification, audits, and monitoring of distributor quality KPIs.
• Bachelor's degree or equivalent in Science, Pharmacy or related discipline.
• Minimum 3 years of experience in the related field, preferred in medical device or pharmaceutical industry.
• Experience in QC or related fields.
• QC exposure to quality standard e.g. ISO, GMP, GDP, RA requirements will be desirable.
• Have knowledge of GMP and/or equivalent Quality Assurance Systems.
• Capability to communicate and good coordination and interpersonal skills.
• Good command of written and spoken Thai and English together with computer literacy.

Experience:

3 years required

Skills:

Thai, English

Job type:

Full-time

• Creates a plan to achieve objectives through sales and servicing of customers in a prescribed territory.
• Schedules appointments and makes preplanned sales presentations to customers.
• Identify new customers, increase new listing and maintain partnership with key opinion leaders and key prescribers.
• Initiates contact and schedules appointments with potential new customers.
• Makes effective visits to customer locations to gather information on orders and market conditions.
• Prepares sales reports, market intelligence data and documents as required.
• Follows up with customers to resolve any issues and ensure satisfaction in timely manner.
• Provides input to sales forecast and closely monitor on sales performance.
• Collects and utilizes all necessary marketing information. Identifies potential impacts to business such as e-bidding and tender.
• Participate in special project to improve company performance.
• Comply with the company's policies and SOPs.
• Bachelor's degree graduate in Pharmacy.
• 2-3 years of direct experience as Medical Representative, Sale Representative, Product Specialist in Pharmaceutical business especially in Immunology and have experience (Hybrid Area).
• Good command of Thai & English in speaking, reading and writing.
• Presentation skill, computer literacy.

Skills:

Marketing Strategy, Research

Job type:

Full-time

• Develop and work with SEA BW & CNV country leads to execute a comprehensive marketing strategy that supports the company's business objectives and drives revenue growth.
• Drive the cross-functional and cross-organizational delivery of the strategy and global product portfolio marketing plans, including value propositions, positioning, and segmentation.
• Partner with Regional Clinical/ Education team for clinical claims, competitive mess ...
• Partner with broader commercial team to successfully deliver on business plans and execute global strategies in each region, driving regional alignment and leverage resource and best practice sharing.
• Lead NPI process and drives governance and product life cycle management by collaborating with local, APAC & Global team on implementation of plans in local markets.
• Lead in development and usage of business dashboards and drive data driven decision making.
• Acquire market, category, KOL insights to collaborate with clinical and commercial team to develop new market and channel strategy.
• Partner with Regional Clinical/ Education team to lead key opinion leadership engagement with customers and internal management, including symposiums, congresses, and educational sessions.
• Assist in the development of short-term tactical marketing plans and longer-term product business plans.
• Develop and manage regional marketing budgets, ensuring that all expenditures are within budget and aligned with the company's goals.
• Education:
• Bachelor's degree in business administration, Marketing, Engineering, and advanced degree is preferred.
• Required:
• 8-10 years of relevant business experience in Marketing, General Management, Clinical research, or a related field, preferably medical device.
• Demonstrated ability to operate in highly complex, hybrid and diversified markets.
• Excellent communication skills, both written and verbal, with the ability to communicate effectively with all levels of the organization.
• Proven ability to lead through influencing cross-functional and senior management to impact decision -making.
• Proven behaviors as a strong partner and team player with diverse functions namely education, clinical affairs, commercial, regulatory affairs, clinical affairs, supply chain and operations.
• Strong interpersonal skills and the ability to develop and maintain strong relationships with external partners.
• Strong analytical skills and the ability to use data to inform decision-making.
• Preferred:
• Cardiovascular industry and clinical electrophysiology knowledge with proven ability to learn complex technology/clinical applications is preferred.
• Experience in marketing to health professionals preferred.
• Other:
• Strong entrepreneurial mindset & leadership qualities.
• Strong desire to learn along with professional drive.
• Passion for career development and regional exposure, ability to travel independently.

Experience:

3 years required

Skills:

Compliance, Finance, CPA

Job type:

Full-time

• Drive business financial performance. Play a key role in tracking and shaping the business performance towards financial commitments.
• Explore and drive for profitability improvement initiatives e.g. pricing and profitability, resource allocation, and cost effectiveness.
• Strategic / Business Planning & Financial forecasting and reporting:
• Partner with Commercial team for business planning.
• Collaborate with Commercial team to provide an accurate financial forecast with risks and opportunities clearly identified.
• Ensure timely and accurately reports to Global / Regional teams, employing planning systems as needed.
• Improve current planning processes in driving better accuracy, efficiency & simplicity.
• Business partnering and Compliance.
• Continuously raise awareness of compliance requirements within Business and ensure compliance within Finance function.
• Keep SOPs updated and are fully adhered. Timely remediate any anticipated control concerns.
• Closely work with other functions of Finance for a timely and accurately financial close.
• Essential knowledge and skills:
• A Bachelor's degree with 3-5 years of experience in business partnering Finance roles.
• MBA / Professional certification (e.g. ACCA/CA/CPA/CMA) will be a plus.
• Strong communication, presentation, and inter-personal skills.
• Core competencies required for this role:
• High Integrity.
• Teamwork.
• Critical thinking.

Experience:

3 years required

Skills:

Thai, English

Job type:

Full-time

• Creates a plan to achieve objectives through sales and servicing of customers in a prescribed territory.
• Schedules appointments and makes preplanned sales presentations to customers.
• Identify new customers, increase new listing and maintain partnership with key opinion leaders and key prescribers.
• Initiates contact and schedules appointments with potential new customers.
• Makes effective visits to customer locations to gather information on orders and market conditions.
• Prepares sales reports, market intelligence data and documents as required.
• Follows up with customers to resolve any issues and ensure satisfaction in timely manner.
• Provides input to sales forecast and closely monitor on sales performance.
• Collects and utilizes all necessary marketing information. Identifies potential impacts to business such as e-bidding and tender.
• Participate in special project to improve company performance.
• Comply with the company's policies and SOPs.
• Bachelor's degree graduate in Medical Technology or other related filed.
• 2-3 years of direct experience as Medical Representative, Sale Representative, Product Specialist.
• Good command of Thai & English in speaking, reading and writing.
• Presentation skill, computer literacy.