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6-10 years
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Avatar of Tina Chou.
Avatar of Tina Chou.
Past
台灣研發中心-醫材法規人員(Medical Device Regulatory Affair Specialist at Taiwan RD center) @澳門商原妙醫學科技有限公司台灣分公司 (Honest Medical Equipment Macau Co., Ltd. Taiwan Branch)
2021 ~ 2023
Regulatory Affair Specialist
Within one month
sales chief to train the new trading specialists, assign and supervise their work. My second job is as an international trade specialist for importing European, USA, Japan, China & Nepal ophthalmic medical equipment as the authorized distributor. Except for international trade tasks, I was also responsible for product registration affairs. I had to apply for Quality System Documentation (QSD) and register a product importing license for foreign manufacturers for importing legally. This has allowed me to promote more practical experiences regarding registration affairs and I also participated in many regulatory courses in the past four years.
International Trade
ISO 13485:2016
Medical Device Quality Management System Regulations
Unemployed
Ready to interview
Full-time / Interested in working remotely
10-15 years
文藻外語學院
英國語文學系
Avatar of 陳毓茹.
Avatar of 陳毓茹.
Medical translator @Exfluency
2022 ~ Present
法規人員、臨床試驗專員
Within one month
Additionally, I played a pivotal role in the translation of technical documents, including Informed Consent Forms (ICF), Comprehensive Study Protocols (CSP), Clinical Study Reports (CSR), and various guidelines pertinent to clinical study projects. This multifaceted experience has equipped me with a comprehensive understanding of the intricacies of drug development, regulatory compliance, and effective communication within the pharmaceutical industry Working Experience Senior regulatory affairs specialist • CMIC Holdings Co., Ltd. FebPresent 1. Wrote a customized regulatory gap analysis report on oncological drugs for NDA submission 2. Support writing a BSE report (Oncology drug) and constructing the BSE
powerpoint
專案管理
outlook
Employed
Ready to interview
Full-time / Interested in working remotely
4-6 years
National Cheng Kung University
Pharmacology
Avatar of Anatoly Bogdanov.
Avatar of Anatoly Bogdanov.
self-learning @Student QA Engineer
2020 ~ Present
QA engineer
Within two months
User testing QA Engineer Product Business research Language Russian ・ Native English・Beginner Spanish・Beginner Professional Experience MarchPresent Learning JavaScript, TypeScript, Python, GIT, and QA Engineer. Troublehacking, Troubleshooting, QA Engineer, AWS, Cloud Google. CEO • NETFOX Ltd JanuaryMarch 2020 Registrar of domain names RF and RU, Data Center Operations Engineer, Regulatory Affairs Specialist, Data Center Innovation Manager, Web Hosting Customer Support, Affiliate Program Management, QA, Marketing Department, Troublehacking, Troubleshooting, The first use of a remote reset button in Russia for hosted servers in ATX cases. CEO • Internet agency RE: Play JanuaryDecember 2006 Web Hosting Customer Support, Affiliate Program Management
Studying
Full-time / Remote Only
More than 15 years
Avatar of Muhammad Iqbal.
Avatar of Muhammad Iqbal.
Pharmacist @PT. Kimia Farma Trading & Distribution Cabang Malang
2018 ~ 2023
Pharmacist
Within one year
PT. KIMIA FARMA APOTEK NovemberDesember 2017 I am in charge of helping give communication, information, and education to patients. Education Gadjah Mada University Master of Pharmacy ManagementAirlangga University Bachelor of Pharmacy and Pharmacist ProfessionHard Skills SAP Microsoft Excel Microsoft PowerPoint Google Things Soft Skills Management Skills Communication Skills Regulatory Affairs Teamwork Languages English — Intermediate Bahasa Indonesia - Fluent Projects Audit Good Drug Distribution Method (CDOB) This audit has been carried out in 2022 for three categories, namely Other Drugs, Cold Chain Products, and Narcotics from the Drug Supervisory Agency of the Republic of Indonesia (BPOM RI) Master of Management
Pharmaceutical Management
Managing Inventory
Regulatory Affairs
Full-time / Interested in working remotely
4-6 years
Universitas Gadjah Mada
Master Pharmacy Management
Avatar of A S M Sultan Mahmud Reza Khandaker.
Avatar of A S M Sultan Mahmud Reza Khandaker.
Sales Manager @Agro Link BD
2018 ~ 2023
Sales Manager
More than one year
kinds of 'on the job situation both mentally and physically. Proven track record in agricultural farm management Work Experience Sales Manager • Agro Link BD OctoberMarchMaking sales plan, sales budget preparation, monitoring sales officers' activities, provide training program, market channel linkage, achieve sales and collection target. 2. Oversee regulatory affairs, merchandising, product pricing and distinctive new product development to lead the market 3. Develop innovative marketing campaigns to increase engagement with target demographic and drive brand exposure. 4. Create effective strategies to target new markets after researching and analyzing competitor behavior. 5. Job
Potential
Ability To Work Independently
Develop Strategies
Full-time / Interested in working remotely
More than 15 years
University of Rajshahi
Marketing
Avatar of the user.
Avatar of the user.
Sell-Side Equity Research Analyst, TMT @Oscar Gruss Inc
2006 ~ 2010
Strategic Alliance Manager
More than one year
5G
Telecommunications Industry
Strategic Partnerships
Employed
Full-time / Interested in working remotely
10-15 years
Harvard Division of Continuing Education
Advanced Executive Communications Program
Avatar of Ruby Fang.
法規經理
Within six months
方韻茹 Ruby Fang 關於我 - 於化妝品/食品相關產業有9年以上經歷 - 專精於產品管理/產品法規/產品行銷 - 擅長公開授課演講 - 具良好組織性及專業邏輯思考能力,及良好跨部門合作及溝通能力 eMail: [email protected] 聯絡電話:居住地: 台北市 學歷 Kansas State University
Word
PowerPoint
Google Drive
Full-time / Interested in working remotely
6-10 years
Kansas State University
化妝品及食品產品管理與產品法規
Avatar of the user.
Associate Medical Officer
Within one year
Medical Devices
Regulatory Affairs
Full-time / Interested in working remotely
More than 15 years
Cochlear Foundational Curriculum
Mapping
Avatar of Katarzyna Reiss.
Avatar of Katarzyna Reiss.
Specialist within INTERNATIONAL DESK @UniCredit Group
2008 ~ 2008
Head of Overseas Marketing Office/Head of Regional Sales CIS/CEE
More than one year
overall oversees execution, adapt strategy and tactics to ensure successes in the market; deploy marketing support and train partner; proactively collaborating with the team of the different affiliates to drive product knowledge and grow the sales; participation at local events and conferences Management: Coordinate with other departments of Moleac: Logistics, Regulatory, Global Marketing, Medical Affairs, Moleac Singapore - Head of Global Marketing JanJan 2014, location SINGAPORE, BIOPOLIS Development and implementation of long term PR/marketing strategies Working closely with the CEO, Medical Directors, taking sole responsibility for the planning and delivery of all marketing and communications, monitoring press releases, delivering
Employed
Full-time / Interested in working remotely
10-15 years
Jagiellonian University
Postgraduate studies „Business in biotechnologii”,
Avatar of the user.
Avatar of the user.
Head of Legal @Center for Breakthrough Medicines
2020 ~ Present
More than one year
general corporate counsel
Life Science Industry
Biotechnology
Part-time / Interested in working remotely
More than 15 years
The University of Texas School of Law
Doctor of Law

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Profile 03 00@2x 0f8539d7f013fd11030f4f7a7b97caf8c2dc5732bc61cba71764f3365c568794

Cindy Greatrex

Responsible for the development, implementation and ongoing review of the enterprise wide continuum of care case management integrated system. Provide leadership and direction to implement the case management plan across the continuum consistent with mission, values, goals and objectives. Scope of the position includes: Hospital utilization review Clinical research study coordination Hospital transition planning/social services functions Care Coordination Institute (CCI) long term complex case management and risking risk intervention program Transitional care program Post-Acute Care Team (PACT) readmission reduction program Palliative Care Services (inpatient and outpatient) Hospital based chronic disease management services Post hospital discharge call back/follow up programsDiabetes Education Aligned post-acute partner relationships Physician liaison Other case management programs to be determined based on need Participate with leaders of the hospitals, medical staff, medical group practices, managed care, Post acute care, community stakeholders and clinical areas to achieve optimal clinical and financial outcomes. Directs and coordinates the planning, organizing, prioritizing, implementation and evaluation of the activities and associates engaged in care management. Assure compliance and oversees the operational processes of case management consistent with regulatory and third party payer requirements and regulations. Highly engaged with Payors and Value based contracts along with ACO and ACO committees. Mission: To enhance the physical, mental and emotional well-being of the communities we serve as the community’s provider of outstanding quality, superior value and comprehensive health care services. Vision: Innovative health care and well-being services of the highest quality at the greatest value Easy access and convenience Outstanding patient experiences Ongoing education involving physicians, patients and the community Through experience have demonstrated flexibility, resilience and ability to be successful with increasing responsibility in dynamic health care environment. Knowledge & Skills Understanding of benchmarking, case management concepts, current reimbursement practices and requirements of third party payers and clinical care and disease management practices, procedures and techniques. Understanding of Medicare, Medicare Advantage and Medicaid programs and third party payer medical policy requirements. Understanding of and proven ability to reduce LOS and readmission for ACO, Bundled payment programs, Value Based contracts and Value Based purchasing. Adept in interactions/negotiations with community agencies, services and resources available to assist patients/families with identified needs to meet health goals. Ability to operationalize the requirements of Milliman and Interqual care guidelines within the department. Can proactively manage authorization challenges for care being delivered. Highly effective managerial skills including planning, organizing, delegating, coaching, and facilitating and coordinating staff activities. Can motivate associates and foster collaboration, creativity and engagement. Highly developed leadership skills that enable one to make sound decisions, mediate and resolve conflicts between multiple decision-making groups, and handle diverse and complex problems. High level analytical skills necessary to plan, organize, formulate innovative solutions and compile, analyze and evaluate data and prepare accurate reports. Broad knowledge and successful leadership in performance improvement activities. Strong interpersonal skills necessary to promote and maintain cooperative and courteous relationships between individuals with disparate interests. Advanced, effective communication skills, including verbal, written, and listening skills. Technological skills and knowledge to successfully utilize hospital computer systems and software programs involved continuum of care case management activities. Case Management Program Development In a dynamic healthcare system, establish/continuously improve team structures, responsibilities, and relationships to effectively and efficiently manage medical necessity of admissions to the hospitals, duration of stays, professional services furnished, processes ensuring compliance, community outpatient based care coordination, and proactive health and disease management efforts. Develops and communicates outcomes and projected time frames for plan objectives to any audience. Accountable to maximize strategic initiatives to achieve high level clinical integration and standardization of work processes, policies/procedures, administrative processes, and other necessary efforts to maximize efficiency and effectiveness of the program. Demonstrate high level skill in navigating successful relationships with third party payers representing patient and the health system. Communicate and gather feedback from interested stakeholders regarding plans and direction for the case management function. Organize information from multiple sources into meaningful reports and communications. Serve as a liaison and contact person for concerns and questions relative to case management, care coordination, social work services and utilization management. Establish productive steering/advisory mechanisms where indicated to support collaboration and integration efforts. Leadership of the Case Management Function Identifies required resources and develops and effectively administers budgets in assigned areas. Develop and monitor lead and lag measures which serve to assess the effectiveness of case management processes. Assure case management workforce demonstrates consistent knowledge and skill requirements for effective case management practice and develops methods to assess initial and assure ongoing competency. Identify and recommend appropriate staffing levels to achieve the goals of case management efficiently provided. Monitor and align departmental processes to support reduction in exposure to payment denials, quality or patient safety issues or other untoward organizational outcomes. Develop effective collaborative relationships with other organizational leaders. Regulatory Compliance and Performance Improvement Prepare/ensure that appropriate records, reports and statistical studies are completed for compliance documentation regarding Beacon Health System standards and external regulatory agency requirements. Assure effective functioning of Utilization Review Committees of each acute care hospital. Serve as a Hospital and Health System resource regarding revenue cycle, transition planning and social work services topics and identifies, leads and participates in performance improvement activities as needed. Work cooperatively with the Denials and Appeals and Managed Care department to analyze contract and payment activity and improve performance of internal work processes to avoid payment risk. Human Development Assure effective functioning of all delegated leaders of various functions in the case management enterprise continuum. Conducts performance reviews in accordance with established policies and procedures. Work collaboratively with physician liaison to support medical staff in case management processes including designing effective programs for case reviews, third party provider interactions, medical staff continuous learning to maximize working knowledge of payer practices, medical necessity requirements and documentation. Through regular effective communication with associates in the case management continuum assures engagement/alignment with program goals and objectives. Foster effective program development and process improvement through efforts to involve associates at all levels in design and performance improvement efforts. Contribution to Effectiveness of Program and Health System Maintains personal competence in Case Management processes and remains continuously current re: issues and trends in the industry. Completing other job-related assignments and special projects as directed. Manages the population health business risk of the Health System Ability to influence behavior and drive change with the population managed in the ACO, and value based contracts Experience in developing relationships with Health plans and payors Development of metrics and dashboards to track progress Directs the establishment and enforcement of standardized processes Attend and participate in department meetings and is accountable for all information shared. Complete mandatory education, annual competencies and department specific education within established timeframes. Complete annual employee health requirements within established timeframes. Maintains license/certification, registration in good standing throughout fiscal year. Direct patient care providers are required to maintain current BCLS (CPR) and other certifications as required by position/department. Consistently utilizes appropriate universal precautions, protective equipment, and ergonomic techniques to protect patient and self. Adheres to regulatory agency requirements, survey process and compliance. Complies with established organization and department policies.

Associate Medical Officer
La Jolla, US
[email protected]

Resume
Profile
Profile 03 00@2x 0f8539d7f013fd11030f4f7a7b97caf8c2dc5732bc61cba71764f3365c568794

Cindy Greatrex

Responsible for the development, implementation and ongoing review of the enterprise wide continuum of care case management integrated system. Provide leadership and direction to implement the case management plan across the continuum consistent with mission, values, goals and objectives. Scope of the position includes: Hospital utilization review Clinical research study coordination Hospital transition planning/social services functions Care Coordination Institute (CCI) long term complex case management and risking risk intervention program Transitional care program Post-Acute Care Team (PACT) readmission reduction program Palliative Care Services (inpatient and outpatient) Hospital based chronic disease management services Post hospital discharge call back/follow up programsDiabetes Education Aligned post-acute partner relationships Physician liaison Other case management programs to be determined based on need Participate with leaders of the hospitals, medical staff, medical group practices, managed care, Post acute care, community stakeholders and clinical areas to achieve optimal clinical and financial outcomes. Directs and coordinates the planning, organizing, prioritizing, implementation and evaluation of the activities and associates engaged in care management. Assure compliance and oversees the operational processes of case management consistent with regulatory and third party payer requirements and regulations. Highly engaged with Payors and Value based contracts along with ACO and ACO committees. Mission: To enhance the physical, mental and emotional well-being of the communities we serve as the community’s provider of outstanding quality, superior value and comprehensive health care services. Vision: Innovative health care and well-being services of the highest quality at the greatest value Easy access and convenience Outstanding patient experiences Ongoing education involving physicians, patients and the community Through experience have demonstrated flexibility, resilience and ability to be successful with increasing responsibility in dynamic health care environment. Knowledge & Skills Understanding of benchmarking, case management concepts, current reimbursement practices and requirements of third party payers and clinical care and disease management practices, procedures and techniques. Understanding of Medicare, Medicare Advantage and Medicaid programs and third party payer medical policy requirements. Understanding of and proven ability to reduce LOS and readmission for ACO, Bundled payment programs, Value Based contracts and Value Based purchasing. Adept in interactions/negotiations with community agencies, services and resources available to assist patients/families with identified needs to meet health goals. Ability to operationalize the requirements of Milliman and Interqual care guidelines within the department. Can proactively manage authorization challenges for care being delivered. Highly effective managerial skills including planning, organizing, delegating, coaching, and facilitating and coordinating staff activities. Can motivate associates and foster collaboration, creativity and engagement. Highly developed leadership skills that enable one to make sound decisions, mediate and resolve conflicts between multiple decision-making groups, and handle diverse and complex problems. High level analytical skills necessary to plan, organize, formulate innovative solutions and compile, analyze and evaluate data and prepare accurate reports. Broad knowledge and successful leadership in performance improvement activities. Strong interpersonal skills necessary to promote and maintain cooperative and courteous relationships between individuals with disparate interests. Advanced, effective communication skills, including verbal, written, and listening skills. Technological skills and knowledge to successfully utilize hospital computer systems and software programs involved continuum of care case management activities. Case Management Program Development In a dynamic healthcare system, establish/continuously improve team structures, responsibilities, and relationships to effectively and efficiently manage medical necessity of admissions to the hospitals, duration of stays, professional services furnished, processes ensuring compliance, community outpatient based care coordination, and proactive health and disease management efforts. Develops and communicates outcomes and projected time frames for plan objectives to any audience. Accountable to maximize strategic initiatives to achieve high level clinical integration and standardization of work processes, policies/procedures, administrative processes, and other necessary efforts to maximize efficiency and effectiveness of the program. Demonstrate high level skill in navigating successful relationships with third party payers representing patient and the health system. Communicate and gather feedback from interested stakeholders regarding plans and direction for the case management function. Organize information from multiple sources into meaningful reports and communications. Serve as a liaison and contact person for concerns and questions relative to case management, care coordination, social work services and utilization management. Establish productive steering/advisory mechanisms where indicated to support collaboration and integration efforts. Leadership of the Case Management Function Identifies required resources and develops and effectively administers budgets in assigned areas. Develop and monitor lead and lag measures which serve to assess the effectiveness of case management processes. Assure case management workforce demonstrates consistent knowledge and skill requirements for effective case management practice and develops methods to assess initial and assure ongoing competency. Identify and recommend appropriate staffing levels to achieve the goals of case management efficiently provided. Monitor and align departmental processes to support reduction in exposure to payment denials, quality or patient safety issues or other untoward organizational outcomes. Develop effective collaborative relationships with other organizational leaders. Regulatory Compliance and Performance Improvement Prepare/ensure that appropriate records, reports and statistical studies are completed for compliance documentation regarding Beacon Health System standards and external regulatory agency requirements. Assure effective functioning of Utilization Review Committees of each acute care hospital. Serve as a Hospital and Health System resource regarding revenue cycle, transition planning and social work services topics and identifies, leads and participates in performance improvement activities as needed. Work cooperatively with the Denials and Appeals and Managed Care department to analyze contract and payment activity and improve performance of internal work processes to avoid payment risk. Human Development Assure effective functioning of all delegated leaders of various functions in the case management enterprise continuum. Conducts performance reviews in accordance with established policies and procedures. Work collaboratively with physician liaison to support medical staff in case management processes including designing effective programs for case reviews, third party provider interactions, medical staff continuous learning to maximize working knowledge of payer practices, medical necessity requirements and documentation. Through regular effective communication with associates in the case management continuum assures engagement/alignment with program goals and objectives. Foster effective program development and process improvement through efforts to involve associates at all levels in design and performance improvement efforts. Contribution to Effectiveness of Program and Health System Maintains personal competence in Case Management processes and remains continuously current re: issues and trends in the industry. Completing other job-related assignments and special projects as directed. Manages the population health business risk of the Health System Ability to influence behavior and drive change with the population managed in the ACO, and value based contracts Experience in developing relationships with Health plans and payors Development of metrics and dashboards to track progress Directs the establishment and enforcement of standardized processes Attend and participate in department meetings and is accountable for all information shared. Complete mandatory education, annual competencies and department specific education within established timeframes. Complete annual employee health requirements within established timeframes. Maintains license/certification, registration in good standing throughout fiscal year. Direct patient care providers are required to maintain current BCLS (CPR) and other certifications as required by position/department. Consistently utilizes appropriate universal precautions, protective equipment, and ergonomic techniques to protect patient and self. Adheres to regulatory agency requirements, survey process and compliance. Complies with established organization and department policies.

Associate Medical Officer
La Jolla, US
[email protected]