เงื่อนไขการค้นหา

ประสบการณ์:

3 ปีขึ้นไป

ทักษะ:

Compliance, Purchasing, GMP, Thai, English

ประเภทงาน:

งานประจำ

• 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.

ทักษะ:

Project Management, Negotiation, English

ประเภทงาน:

งานประจำ

• Developing and leading oncology's pricing, access, and reimbursement strategies through cross functional networking at local and regional levels.
• Supporting the development and execution of integrated value and access strategies relevant to assigned portfolio which align with the wider external affairs strategy and support the achievement of the organization's commercial goals.
• Building and maintaining a deep understanding of the payer landscape, including barriers and opportunities.
• Informing and executing strategic pricing decisions in assigned portfolio, including collaborating with the Head of Market Access, regional market access, and global pricing team on value-based pricing.
• Collaborating with the assigned portfolio BUD to develop market access strategy plans, with a particular emphasis on oncology - key growth drivers and priority products.
• Developing and communicating value propositions for each key stakeholder to achieve market access objectives.
• Developing and communicating evidence submissions to relevant HTA and / or other decision-taking processes.
• Shaping tender design in key therapy areas.
• Designing bespoke approaches to the out-of-pocket market in Thailand, including through business-to-business.
• Identification, analysis, and communication of economic barriers and gaps to access.
• Supervising the development, adaptation, and implementation of Health Economic (HE) models and programs to meet customer needs and achieve commercial targets.
• o Determining outcomes research requirements and developing local data generation strategies in collaboration with a respective TA market access manager.
• o Preparing health technology assessment and dossiers for National listing of essential medicines (NLEM) and tendering submissions.
• o Searching literature and critically reviewing, extracting, and summarizing relevant evidence.
• o Supporting the wider external affairs team to engage in evidence-based conversations with key stakeholders as appropriate.
• o Developing strategy and design, in collaboration with medical affairs, of local data generation studies.
• Real world local data generation (LDG) projects:
• o Designing market access LDG projects in alignment with CORE.
• o Overseeing the data procurement, data analysis, and reporting.
• o Overseeing the publication of findings and dissemination of finding to commercial teams.
• o Present at conferences on the topic of health economics and LDG findings to strengthen value and affordability cases to key leaders in the industry.
• o Develop good relationships with KOLs based on a shared interest in research and scientific methodologies.
• o Provide strategic input into market access and commercial plans.
• o The building of models to explore different scenarios in order to inform strategic decisions. E.g. alternative reimbursement models, business case models for new product launches, pricing strategies, etc.
• o Assist with the analysis of current data and trends, partnering with the relevant market access managers in guiding the commercial teams on strategic decisions.
• o Leadership and strategic counsel.
• Maintaining up-to-date internal knowledge of pricing, listing and tendering systems, including submissions of PARFs for senior leadership and Global approval.
• Developing a thorough understanding of the policy objectives, health priorities, and planned initiatives of government, particularly as they may impact on access for company's oncology franchise.
• Collaborate with Policy colleagues in the assessment of and development of action plan to shape the value frameworks and other policies impacting value assessment.
• Monitoring access and pricing environment.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• University educated to a high level (Bachelor's degree is required; advanced/graduate degree preferred (PhD, MPH, MPP, MBA, other)).
• 5-7 years' experience of the pharmaceutical sector in Thailand.
• Experience of working at a senior level in a market access, marketing or HEOR role.
• Detailed knowledge of the key market access issues relating to oncology or vaccine business, and experience of working to overcome them.
• Evidence of strategic and analytical thought.
• Proven track record of success in developing and implementing access strategies.
• Proven ability to establish strong influential relationships with key stakeholders/government officials.
• Strong organizational and project management skills.
• Demonstrated leadership skills and experience leading and managing cross-functional teams within a matrix organization.
• Demonstrated ability to influence and lead without direct reporting relationships; be a change agent to the cross-functional teams.
• Demonstrated aptitude with commercial & strategic thinking.
• Interpersonal effectiveness, particularly in working productively under pressure with team.
• Fluent English language skills.
• Critical competencies for success.
• Ability to navigate the market access environment: the market access manager will be able to assist in identifying optimal routes to reimbursement, and help develop and address any needs and requirements of the routes identified - including requirements for HTA and/ or tender processes as appropriate.
• Understanding of the payer mindset: the market access manager will have an understanding of, and insights into, the attitudes of payers.
• Other personal characteristics.
• Other desirable personal characteristics include being:
• Highly committed.
• Able to engage a complex set of issues.
• Attentive to detail.
• Of impeccable integrity.
• Calm under pressure.
• Good communication and negotiation skills.
• Able to work in a highly dynamic situation.
• Ability to embrace a mindset of Networking, Empowering, Experimenting, Sharing & Learning, whilst maintaining focus on Purpose, High Integrity &Ethics, Patient-Focus and Diversity & Inclusiveness.
• Our Human Health Division maintains a "patient first, profits later" ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
• has context menu.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular
• Relocation:
• Domestic
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R285989.

ประสบการณ์:

3 ปีขึ้นไป

ทักษะ:

Thai, English

ประเภทงาน:

งานประจำ

• 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.

ทักษะ:

English, Thai

ประเภทงาน:

งานประจำ

• Lead cross-functional market access team to gather evidence which support payer value proposition and pricing strategy.
• Represent patient access in all major cross-functional teams at the program/brand level including Global Programme Teams, Global Brand Team and Global Medical Affairs Teams.
• Head of Market Access is a key strategic leadership role mandated to establish and build relationships with key influencers and decision makers for both private and pub ...
• This role will need to be diligent in focusing on cross functional alignment and collaboration while ensuring focus on priority assets in key markets to ensure the highest possible rate of success and return as measured by fast patient access while meeting overall revenue objectives.
• Commitment to Diversity & Inclusion:
• We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Role Requirements.
• Postgraduate degree in sciences, business administration, health policy, health economic or other relevant qualification.
• Deep understanding of payer/HTA across countries/regions.
• Experience with reimbursement dossier compilation.
• Strong Digital & Technology expertise.
• Results-driven and with passion for speed and precision.
• Innovative and highly systematic.
• Able to understand changing dynamics of Pharmaceutical industry.
• Proficient and fluent in English & Thai languages (spoken and written), with good interpersonal and communication skills.
• Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
• You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
• Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
• Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Division.
• International
• Business Unit.
• APMA IMI
• Work Location.
• Bangkok
• Company/Legal Entity.
• NOV THA
• Functional Area.
• Market Access
• Job Type.
• Full Time
• Employment Type.
• Regular
• Shift Work.
• No
• Early Talent.
• No