דרושים ב-Msd ב-South Korea, Seoul

Job Description

Sr Market Access Specialist (TA : Oncology) will lead product patient access and closely collaborate with various cross function both in local and global. This role requires resilience and sufficient expertism

• Lead the planning of access strategies to ensure optimal pricing and access condition in align with business priorities and global access strategies

• Lead communication with internal and external stakeholders for the responsible products to ensure successful patients access in Korea

• Lead local model adaptations to demonstrate product value and local data generation with the engagement of internal/external stakeholders. (eg. CORE, GMAx and Medical/HTA societies)

• Collaboration with business unis to plan product forecasting and gather competitor intelligence. Also forecast environmental changes and price/reimbursement impact to maximize business opportunities

[Qualifications]

• Minimum 7 years’ experience in market access or HEOR either in pharmaceutical industry, academy or HTA agency required

• Bachelor’s degree (or above) of pharmacy, pharmaco-economics, statistics or science preferred

• Understanding of healthcare system, HTA, healthcare policy

• Excellent teamwork, Communication skill, Result-driven and Patient-focused behavior

• Oncology market access experiences are preferred

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.
Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased.
o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

• Provide general ledger support and analysis inclusive of period end financial close responsibilities for US-GAAP and K-GAAP reporting by interacting with external auditors.
• AH (Animal Health) entity financial closing
• Provide support across General Ledger and other AtR sub-process activities
• Maintain an accurate and current accounting ledger which reflects the company's transactional reality through timely posting of all required items
• Responsible for monthly Account Reconciliation processes on a timely basis and adhering to all corporate standards and guidelines
• Review and sign off of the final financial package and the Balance Sheet Reconciliations
• Perform Trial Balance review with the ability to identify and communicate trends, perform analyses on variances and provide a general understanding of all accounts, with support of senior colleagues
• ACVA documentation and follow-ups with customs office
• Tax return for CIT and VAT
• Cost accounting for both HH(Human Health) and AH(Animal Health)
• Yearly TP(Transfer Price) preparation
• Internal/external audit preparation
• Preparation of BOD meeting report
• Monthly reconciliation of inventory, obsolescence & valuation.
• Internal Control for both HH(Human Health) and AH(Animal Health)
• Lead and execute the development of internal control program, working closely with global accounting standard & internal control SOX team.
• Conduct risk assessment and collaboration with process owners to build knowledge and understanding of risks and controls.
• Ensure accurate and timely period reporting that complies with Corporate and country requirements

Education & Experience Required:

• Bachelor’s Degree in Business Administration, Accounting or Finance preferred
• AICPA preferred
• Minimum of 4 years of experience in a finance or accounting department of a multinational company including demonstrated.
• Fluent in English (speaking and writing)
• Experience with US and Korean GAAP

Technical Skills Requirements:

• Ability to work independently and with a team in a fast-paced and high-volume environment with emphasis on accuracy and timeliness
• Strong communication, interpersonal, and organization skills required
• SAP Experience desired
• Intermediate to Advanced PC skills (MS Excel) required
• Demonstrated commitment to education and professional development
• Ability to operate independently and remain focused through change or uncertainty
• Advanced problem solving and analytical skills with a proactive management style to implement new processes
• Works effectively in a fast-paced, dynamic environment, under pressure and with a high degree of professionalism
• Team player with focus on collaboration with Shared Business Center in Malaysia & Netherland

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

This is 1 year fixed term position (본 채용건은 1년 계약직 포지션입니다)

Job Description

Main acitivities

• Adverse Event Collection and Management
• Individual Case Safety Report and/or Aggregate Safety Report Submission to HA

The other pharmacovigilance activities that can be assigned as required

• Literature Search
• PV Agreement Development and Management, Business Program Support
• Employee Training
• Audit/Inspection Support, Compliance Monitoring
• RMP/PSMP Development and Management

Qualification

• A Bachelor’s degree in Pharmacy, Nursing or Bio/Life Science (Pharmacy major preferred)
• PV experience preferred / Entry level allowed
• English – Fluency in spoken and written
• Microsoft Office, especially Excel - Proficient

Current Contingent Workers apply

Language(s) Job Description:

국내외 규정에 따라 이상사례/안전성 정보를 수집 및 관리하고, 개별이상사례보고서 및/또는 정기안전성보고서를 보건당국으로 제출함

필요에 따라 추가적으로 아래 약물감시 요건을 이행할 수 있음

• 문헌 검색

• PV 계약서 개발 및 관리, 비즈니스 프로그램 지원

• 직원 교육 제공 및 관리

• Audit/Inspection 지원, Compliance 모니터링

• RMP/PSMP 개발 및 관리

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.