Clinical, Medical, Regulatory
7 months ago
Clinical, Medical, Regulatory (CMR) Director
**Category**:Clinical Development**Location**:Ho Chi Minh City, Vietnam, VN**About the Department***
- The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?**Key Responsibilities**
- Affiliate CMR strategy (short, medium and long term) and performance management
- Ensure representation of affiliate in regional and where relevant global boards/meetings
- Member of Vietnam Management team
- Represent the affiliate &/or company with authorities, Business Area Southeast Asia (BASEA)and Global level as assigned by General Manager - NN Vietnam, CMR Director - BASEA
**For Medical**
- Manage and build KOL Engagement plans annually
- Translate global medical affairs and global regulatory strategies into affiliate operational targets
- Implementation of medical projects that support business in general.
- Contributing to medico-marketing strategy and providing support for local business plans to promote the achievement of targets, alignment of cross-functional business activities while ensuring compliance with the country-specific regulatory requirements and relevant legislation
- Align affiliate Medical Affairs goals to Medical Scientific Liaisons (MSLs) priorities, ensuring clear medical communication objectives, supporting material, and trainings
- Ensure effective management and deployment of MSL team, with clear engagement plan, KPIs, and continuous monitoring/evaluation of effectiveness and impact
- Providing qualified medical and scientific support, education and training relevant knowledge (products/ projects) to internal and external stakeholders (e.g.: healthcare professionals, key opinion leaders) on specific products/projects. Support new product launches in the NN Vietnam.
- Review/ certify promotion and non-promotional plans/ materials and drive implementation for current campaigns, jointly determine new product positioning strategies, communication package and empanelment of experts with marketing function, supervise preparation of 'medical backgrounders' for product management team and field staff, address queries of doctors.
- Developing and maintaining relations with customers and KOLs and major institutions in the local health care sector; building local credibility personally and on behalf of Novo Nordisk
- Building and managing the local scientific advisory services for internal and external customers including the management of local department, organize Advisory Boards and providing academic contribution when it is applicable
**For Regulatory and Pharmacovigilance**
- Define the key strategic focuses and plan for RA and PV
- To ensure the department operates in compliance with Regulatory and Pharmacovigilance requirements and allocate resources and provide means that allows employees to fulfil their responsibilities.
**People Management**
- Recruit to full fill all vacant in the CMR function if any. And then set KPIs and review performance, provide development feedbacks, provide on - the - job coaching on NN values and ways of management, encourage informal communication to resolve conflicts, identify training programs and nominate team members for skill development in order to build a motivated team and a positive work environment
**Qualifications**
- Strong medical background, good experience with pharmaceutical industry in addition to an entrepreneurship mindset is required.
- More than 10 years of experiences in medical and clinical fields will be required. Medial/Clinical experiences in Diabetes, Cardiovascular, Obesity, Growth Hormone, endocrinology and Haemostasis areas will be added advantages
- Min. 2-3 years of people management experience will be highly preferred
- Demonstrated experiences in translating clinical evidence into strategies for successful product development and laungch preparation will be preferred
- Excellent communication and leadership skills.
**Working at Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research
-
Hospital/clinic CEO
7 months ago
Ho Chi Minh City, Vietnam HR2B Full time**N/APlan, develop, implement and direct the organization’s operational and fiscal function and performance. Act as a strategic partner by developing and implementing the Hospital/Clinic’s plans and programs. Perform accurate analysis of financial trends and budgets to help HBOD as well as the senior executives to increase credibility and...
-
Regulatory Affairs Intern
7 months ago
Ho Chi Minh City, Vietnam Công Ty TNHH Qualtech Consulting Corporation Full time**Mô tả công việc**: (Mức lương: 4 - 9 triệu VNĐ) **Introduction** Qualtech is an Asia Medical Device Consulting and Clinical Trial (CRO) Company with branch offices in China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Vietnam, Thailand, Korea, USA and Germany. We are looking for a Talented Regulatory Affairs Intern who is...
-
Hospital/clinic CEO
7 months ago
Ho Chi Minh City, Vietnam TẬP ĐOÀN Y KHOA HOÀN MỸ Full timeQuay Lại Trang Tìm Kiếm 5 giờ trước **HOSPITAL/CLINIC CEO**: Ứng tuyển ngay Vị trí TP. HCM và các tỉnh lân cận Lương Thỏa thuận Công ty Tập đoàn Y khoa Hoàn Mỹ Loại hình Full time **JOB SUMMARY**: Responsible for the effective, efficient and integrated operation of a specific hospital/clinic belonging to Hoan My...
-
CEO of Dental Clinics
6 months ago
Ho Chi Minh City, Vietnam Aloha Consulting Group Full timeLead the planning, development, implementation, and direction of the organizations operational and fiscal functions. - Strategically develop and execute plans and programs for the Dental Clinics. - Analyze financial trends and budgets to enhance credibility and decision-making for Clinic BOD and senior executives. - Establish and enhance policies and...
-
Medical Clinic Operation Manager
3 months ago
Thành phố Hồ Chí Minh, Vietnam ICONIC Full timeHiring **OPERATION MANAGER** (New set up **Medical Clinic**) Location: [District 11 - HCM City] New set up Japanese Medical Clinic is hiring Operation Manager to manage the organization and act as a bridge between staff and JP Manager **REQUIREMENT** - Good at English - Experience in managing operations in medical clinic (must) - Have experience in...
-
Senior Clinical Operations Manager
6 months ago
Ho Chi Minh City, Vietnam MSD Full time**Position Overview**: This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on local regulatory and financial compliance and...
-
[vietnam] Medical Science Liaison
6 months ago
Ho Chi Minh City, Vietnam Santen Full timeCompany Description **Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people...
-
Chief Medical Officer
6 months ago
Ho Chi Minh City, Vietnam Aloha Consulting Group Full timeACG_1739_JOB Our client is a leading company providing healthcare services in Vietnam, who is looking for a talent to join their firm: - Provide strategic guidance and leadership to the medical staff, aligning hospital operations with organizational goals and objectives.- - Collaborate with other executives and physician leaders to assess the needs of the...
-
Medical Science Liaison
8 months ago
Ho Chi Minh City, Vietnam Takeda Pharmaceutical Full time**Job Summary**: - Responsible for the execution of the TA specific medical plan in the field, predominantly by establishing, developing, and fostering relationships with key external stakeholders through scientific exchange and research support, always keeping the patient’s needs and safety in focus. - To communicate fair-balanced therapeutic area...
-
Clinic Manager
6 months ago
Ho Chi Minh City, Vietnam Family Medical Practice Vietnam Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) - Making sure the effective day-to-day operations of the Clinic and oversee clinic staff to ensure optimal productivity. Planning and coordinating daily work assignments and operations. - Ensuring compliance with regulations, standards and inspections. - Hiring, mentoring, evaluating manpower. -...
-
Medical Affairs Manager, Vaccine
6 months ago
Ho Chi Minh City, Vietnam Takeda Pharmaceutical Full time**JOB PURPOSE** - This position is responsible for providing strategies for medical affairs within the Therapeutic Area of Vaccines and new launching products. He/she will contribute to the achievement of business success by putting the patient’s needs, diagnosis, access to our medicines, and safety into primary focus by leveraging the understanding of...
-
Medical Affairs Manager, Hio
7 months ago
Ho Chi Minh City, Vietnam Takeda Pharmaceutical Full timeThis position is responsible for providing strategies for medical affairs within the assigned Therapeutic Areas (HIO- Hematology, Immunology, Oncology) and new launching products. He/she will contribute to the achievement of business success by putting the patient’s needs, diagnosis, access to our medicines, and safety into primary focus by leveraging the...
-
Medical Science Liaison
6 months ago
Ho Chi Minh City, Vietnam IQVIA Full time**Job Overview** Engage in scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs **Essential Functions** - Engage in scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs - Identify, renew,...
-
Clinical Representative
6 months ago
Ho Chi Minh City, Vietnam IDS Medical Systems (Vietnam) Limited Full time**Mô tả công việc**: (Mức lương: Thỏa thuận)RESPONSIBILITIES: - Responsible for effective pre-sale demo plan; - Build relationship & network with users and key decision-makers; - Support post-sale user training, ensuring utilization & maximization of features of equipment; - Support FSS Team in product demo and training; - Provide FSS Team...
-
Clinical Research Associate
6 months ago
Ho Chi Minh City, Vietnam IQVIA Full time**Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Clinical Research Associate
7 months ago
Ho Chi Minh City, Vietnam MSD Full time**Job Description**: **Position overview**: 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, Our company policies and procedures, quality standards and adverse event reporting...
-
Senior Clinical Research Associate
7 months ago
Ho Chi Minh City, Vietnam Parexel Full timeThe Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to...
-
Medical Lead for Vaccination Center
3 months ago
Thành phố Hồ Chí Minh, Vietnam Pfizer Full timeRoles summary Strategic planning and development of external stakeholder strategy, execution of external medical to medical engagement according to business unit medical strategy, and alignment with Country Medical Leads on implementation and delivery of medical projects. Lead medical to medical communications in the field. This role considered as field...
-
Clinical Trial Coordinator
6 months ago
Ho Chi Minh City, Vietnam MSD Full time**POSITION OVERVIEW**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Clinical Operations Manager
4 weeks ago
Thành phố Hồ Chí Minh, Vietnam MSD Full time**POSITION OVERVIEW**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...