´ã´ç¾÷¹« / ÀÚ°Ý¿ä°Ç ¹× ¿ì´ë»çÇ×
Pharmacovigilance Associate, Korea
• Bachelor¡¯s degree in life sciences, pharmacy or similar discipline
• Certified Pharmacist
• Working experience is not mandatory
• Less than 5 yrs of working experience in pharmaceuticals, healthcare industry, or academia
• Good knowledge of industry principles and regulations of pharmacovigilance
• Sound knowledge of general medicine or pharmacy and clinical practice
• Good project management skills and effective communication skills
• Excellent verbal and written communication skills in English and Local language
• Handle customer queryrelated to adverse event and manage all serious and non-serious safety reportsin a timely manner via receiving, reporting, documentation, query handling andfollow up
• Develop local risk management plan and implement additional risk minimization activities locally
• Maintain necessary localPV SOPs and supportive documents to ensure compliance with MFDS requirement sand company SOP
• Keep PV agreement with partners/3rd party vendors
• Monitor local iteratures in accordance with company SOP
• Conduct PV training for non PV staff, all sites within the territory and external service providers
• Ensures PV audit /inspection readiness at the LOC and participates as appropriate in PV aud itsand inspection
• Ensure local PV record sand files updated
Career Site: https://takeda.wd3.myworkdayjobs.com/External/job/Seoul-Korea/Pharmacovigilance-Associate_R0012939
Brand Manager, Genetic Diseases, Korea
• Planning brand strategy and followed tactic to achieve brand objectives as a part of the GD BU and corporate goal
• Analyze the competitive market landscape and develop strategic plan to overcome and penetrate the market
• Organize marketing campaign and follow up the implementation to collaborate with sales team
• Manage brand related KPIand other business indicators for seamless business progression and perusingbrand performance
• Brand management
- Establish a brand strategy and setting business plan to deliver business goals.
- Actively interact with Global/Asia franchise for strategic decision, and campaign creation.
- Lead new product launch with multi-functional teams.
- Manage brand P&L and marketing budget
- Develop new product ideas and concepts in line with mid-term business strategy.
• Strategic Sales planning
- Define business opportunitiesthru full understanding of market/competitive landscape and allocate resource
- Engage and lead commercial functions and make timely decision
- Monitor and analyze weekly/monthly sales trend and review monthly Fcst reflecting market demand and business risk
- Implements tactical plan byallocating appropriate resource.
• Marketing Campaign &Communication strategy development
- Manages the execution of communications, research and public relations plans.
- Develops advertising plans to support the marketing plan, identifies appropriate vehicles and messages, andworks with appropriate management to convey needs and image of the company.
- Oversees the management of assigned vendors and agencies.
• Ensure Ethical and Compliant Behavior
- Ensure all activities supporting the Brand/s are compliant with legal requirements in the respective country and Bayer Corporate guidelines and regulations.
- Communicate Takeda¡¯s standard sof Business Ethics and Compliance to both internal and external customers.
• Duties and / or rolesare not limited to details above and may evolve or change during the course of the role based on company priorities and manager¡¯s discretion.
EDUCATION,BEHAVIOURAL COMPETENCIES AND SKILLS:
• Master or Bachelor¡¯s degree in Pharmacy, Biology and Chemistry
• At least 5 years of Marketing experience in Pharma industry
• Preferred the experience in Specialty Medicine (e.g. rare disease)
Commercial acumen and understanding of business financials
Results oriented, resourceful, independent.
Collaboration, interpersonal effectiveness and communication skills
• Excellent in verbal and written English, in addition to local language
Career Site: https://takeda.wd3.myworkdayjobs.com/External/job/Seoul-Korea/Brand-Manager_R0012290
Therapeutic Area Lead, Oncology& Hematology, Korea
Job Title: Therapeutic Area Lead Oncology & Hematology
Department: Medical Affairs
1. PURPOSE OFPOSITION/ROLE
The Medical Therapeutic Area Lead (Oncology & Hematology) contribute to the development of medical strategy and provides Medical input into Brand Strategies and Medical guidance and governance for Takeda Onco-hematology therapeutic area ensuring support of the life cycle of all products. He or she provide sscientific and medical support for key internal and external stakeholders, actively participates in the development of brand strategies for the rapeutic area in accordance with internal corporate policy to ensure that the business objectives of nominated products are realized and the interests of the customer and Takeda are protected.
The person is also responsible for line management & enhancing capabilities of Onco-hematology medial team(Scientific Advisors, MSLs) by coaching and developing emloyees based on capabilities, and actively engaging in individual development plan.
2. KEYACCOUNTABILITIES AND RESPONSIBILITIES
Medical/Scientific Expert Role and Operational Support at Country Level:
• Take part in the development and achievement of strategy, tactics, and operating plan at country evel advancing the marketing of company products and therapeutic area toe nsure that medical plans in specified TA are successfully developed and executed to achieve short- and long-term objectives in alignment with the Global, Regional and Local business strategy goals.
• In compliance and close coordination with the Regional/Korea Medical Director develop key projects to drive products through proper dissemination of medical and scientific information in the country.
• Review regulatory, medical and safety materials from scientific point of view to ensure full compliance with local medical, regulatory and legal requirements. In compliance with ethical business principles provides scientific support and expertise to cross-functional team and other internal stakeholders with respect to material screation and approval, advertising and educational programs, clinical research, medical information, regulatory issues.
• Manage issues that mayadversely affect business. Challenge competitors¡¯ claims and defending Takeda products and promotional materials when challenged
• Support Medical Director in shaping and executing the local annual Medical Budget, owning responsibility for appropriate spending in full alignment with local annual Medical Plan.
• Provide educational support inside cross-functional team at request in appropriate therapy area medical knowledge. When applicable, participates in processes of local medical colleagues development and supervision
• Contribute to development of Regional and Global Clinical Development plans with TDCAensuring local clinical needs are addressed. Support TDCA in clinical trial associated issues in Korea (protocol/site feasibility questionnaires, recommend and support clinical trials centers assessments)
• Provide guidance and review all relevant and required medical contents in accordance with Takeda policies.
External stakeholders relations, Cross functional support and Risk management:
• Target, develop and maintain ongoing relationships with relevant bodies, institutes and key thought leaders for company to ensure that they always have the accurate, updated and comprehensive medical information aligned with Takeda strategies and to foster Takeda's efforts to establish and maintain relevant therapeutic leadership position, including but not limited to:
• Leads advisory boards/consultation meetings and develops the advocacy of the company brand and product brands
• Communicate with health/regulatory authorities in scientific matters
• Review and support Investigator Initiated Research (IIRs), management of associated relationships, including contacts in the appropriate therapy area, communication in study implementation through publication.
• To be consistent with regulatory requirement and SOPs, Medical Advisor provides Risk management of product safety issue, oversight of post-marketing surveillance closely working with medical colleagues, alliance partner and cross-functional team. ,
• Lead by example to promote cooperative and an inclusive way of working together within the medical team members and the cross functional teams
• Provide oversight ofrare hematology, solid tumours & hemato-oncolgy medial team activity andsupport to deliver best-in-class medial affairs activity
• Engage and establish individual development plan through quality conversation with the directreports.
• The employee shall also perform other tasks set by his/her superior within general framework of the employee¡¯s job title
• Duties and / or roles are not limited to details above and may evolve or change during the course of the role based on company priorities and manager¡¯s discretion
3. EDUCATION,EXPERIENCE & SKILLS:
Ideal candidate will have:
• Medical degree (e.g. MD)preferred. Candidates with Pharm degree can be considered if they have sufficient experience in Medical Affairs in Oncology in pharmaceutical industry
• 3-5 years of prior Medical and/or Clinical Affairs experience in pharmaceutical industry
• Preferably 1year of experience in one of the relevant Therapeutic Area (s)- solid tumoirs, hemato-oncology
• Experience creating strategic medical plans & managing budgets
• Minimum 1 year people management experience
• Product launch experience
• Experience conductingadvisory boards
• Managing scientific publications in relevant Therapeutic Area
• In-depth experience in clinical development
Skills &personal characteristics:
• Excellent leadership, managerial, interpersonal and relationship building skills
• Very strong scientific expertise, specifically in the therapeutic area
• Highly collaborative, confident and strong presence
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure
• Able to drive consensus across diverse stakeholders to achieve goals
• Ability to identify and proactively addresses issues before they reach crisis points
• Goal oriented, focused, energetic, and enthusiastic
• Passionate and committed in all undertakings
• Fluent in Korean language
• Excellent verbal and written communication skills in English; fluency in other languages is a plus
• Excellent presentation skills
• IT savvy and process orientated
• Good knowledge of healthcare systems
• A high level of knowledge of regulatory environment including key regulatory agencies and approval processes relevant to the country
Career Site: https://takeda.wd3.myworkdayjobs.com/External/job/Seoul-Korea/Therapeutic-Area-Lead-Oncology---Hematology_R0012817
Quality Assurance Associate
• Quality Assurance associate is responsible for control of qualified product¡¯s release to local market in compliant with local on imported pharmaceutical products with satisfying internal and external global requirements.
• Making sure for local QC test to be timely prepared and performed for seamless product supply by communicating with manufacturing site, supply chain, contract laboratory, warehouse etc.
• Coordinate and support the national release of deputy license product with preparation of summary protocol etc.
• Product complaint and recall handling for marketed product.
• Pre-evaluation and set up of pre-requisite of NDA product QC test and release on timely manner.
• Communication and transfer of rational document for local QC test to contract vendor and support and preparation relating agreement(Confidential agreement and QC service agreement) Obtain MFDS approval for non registered drug product importation for pre-evaluation QC test and obtain KCMA approval for reference material importation for QC test
• QA SOP preparation and its implementation according to Takeda Quality Management System and local regulation.
• Document management and archive relevant documents to meet the Korea drug importer requirement.
• Artwork development and control for NDA product and market product with communicating with TPK RA, Supply chain, global artwork team and manufacturing site to be delivered on timely manner.
• Manage and support of authority inspection regarding quality issue, self inspection, CAPA, Change control, annual product review
• Product quality related deviation, change control handling with its follow up by CAPA
• Perform audit for relevant parties in its business scope including self-audit.
• Evaluate external vendor¡¯s validation documents or perform relevant validation.
• Find and fill the gap between local practice and current internal and external requirements for GMP/GDP area and improve local quality management system continuously.