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Clinical, Medical, Regulatory
2 weeks ago
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 healthcareprovider 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 patientcentered 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 medicomarketing strategy and providing support for local business plans to promote the achievement of targets, alignment of crossfunctional business activities while ensuring compliance with the countryspecific 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 nonpromotional 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. 23 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
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