The Position
1. Job Purpose/Core Accountabilities
Medical expertise is critically important to enable us to rapidly address healthcare needs, opportunities, & barriers to care and create value within the full healthcare ecosystem.
- The Local Medical Enabler is a strategic leadership role together with DAN Enablers, PPOCs and other enablers provides technical and functional expertise to facilitate and pursue our North Star: Deliver Better Outcomes For More Patients Faster, in accordance with relevant local laws, regulations and Roche SOPs
- The Local Medical Enabler requires scientific and therapeutic area expertise (Disease Area, Evidence Generation, drug development, etc) with holistic perspective on disease area (pipeline and on market products) (both internal and external value) and clear business understanding to identify and address the relevant medical needs of clinical practice, to successfully support the optimal use of Roche product.
- The Local Medical Enabler proves his/her enabling ability through a diversity of ways, including establishing valuable partnerships with external stakeholders, co-creating solutions with DAN Enablers, PPoCs and other enablers, shaping the external ecosystem and the future organization, fostering a networked way of working
- The Local Medical Enabler acts as a Medical/scientific Point of Contact in the local organization for their primary Disease/Therapeutic area and executes regular medical affairs tasks in those particular areas, allocate time and effort to work packages and or network tasks and take part in network tasks (in the affiliate or across countries) based on their skills and expertise
- Act as a guardian for high standards of compliance, ethics, and safety of Roche products, putting patients at the center of his/her actions.
- Member of the Medical chapter as well as part of the cross-function Local Disease Team (Enabling Function) and DAN to support the development of Ecosystem’s strategy and the implementation of medical strategies and action plans within his/her competence, play as the pulled resources of PPOCs.
2. Responsibilities & Accountabilities
2.1. Responsible for DA/TA medical expertise:
- Co-create with DAN, PPOCs, local Enablers and other functions to build DA/TA integrated strategies and OBP (DA affiliate outcomes: LTO, MTO & STO)) - aligned with global and regional strategies.
- Prioritize efforts to DAN’s Work Packages requiring highly localized insight or activities
- Local advocacy: co-creation with PPOCs and DAN Medical Enablers to identify, develop, and establish scientific relationships with KOLs in related DA/TA.
- Partnership: Interact with ecosystems in scientific partnership with stakeholders (medical associations, Health authorities, patient advocacy groups, NGOs,...)
- Provide input for the development of Digital integrated personalized offerings and introduce innovation/differentiation related to the offering, ex. added-value services, online education, etc.
- Support Pharmacovigilance activities, including assurance of appropriate adverse event reporting in coordination with Local Safety Responsible.
- Medical review and governance: promotional material review and production, medical release etc., and manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
- Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
- Support Regulatory for any medical/products related information, including preparation of relevant data for new products/indications’ application and label updates.
- Provide related DA/TA medical/scientific support and training for internal staff
- Manage publication related activities according to Roche Policy and SOPs.
- Clinical Research & Evidence generation:
- Support to Clinical Operations (local, global, CRO) in all phases of global (PDG/PDMA) and local study conduct, as applicable: definition of the research questions and study objectives, study design and protocol, study budget, feasibility, site selection, initiation visits, patient recruitment, protocol & patient issues, scientific communication of study results, clinical study report and scientific publications
- Support and collaboratively work with the Access & Policy Chapter, especially the pharmaco-economic, patient advocacy group and government stakeholder team, provide relevant efficacy and safety data on dedicated products, support HTA assessment,…
- Collaborate with the PPoCs in identifying and prioritizing relevant research ideas and developing them into research projects
- Compassionate Use/ Pre-approval Access:
- Manage the evaluation of patient eligibility and all the procedures to activate the eventual treatment approval, importation and supply
- Grants/Donations & Sponsorships
- Manage the evaluation of the research grants requests based on criteria defined at local level and is the final decider
2.2. Compliance
- Identify, collect and report any AE and/or other reportable event and forward to the drug safety department within timelines described in relevant SOPs.
- Identify and report any product quality complaints and forward them to the local complaint manager within timelines described in relevant SOPs.
- Ensure integrity and scientific accuracy of the MI responses if applicable.
- Ensure copyright compliance for documents provided to the customer if applicable
- Ensure that all in-field activities are in line with relevant Vietnamese regulations, the IFPMA, local pharma code and Roche business principles and values
- Be responsible for all aspects of safety, health and environmental protection in the areas under control.
- All Roche employees are expected to practice high standards of compliance following Roche Code of Conduct with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company.
3. Competencies
- Roche Core Competencies
- Strategic Agility
- Communication
- Inspiring and Influencing
- Teamwork and Collaboration
- Achieving Results
- Feedback and Coaching
- Marketing Innovation
- Specialty Competencies
- Medical strategy
- Medical Science and TA Knowledge
- Pharma Drug Development
- Evidence Generation
- Scientific Communications
- Operational Efficiency
- People and Leadership
- Agile
- Experimental
- Take risks
- Managing Change
- Innovation
- Digital health solution oriented
4. Mindset & behaviors
Adopt and continually develop in the following Mindsets & Behaviors is expected to be successful in this role, to contribute to achieving the goals of every team, and enable RPV to follow its Kim Chi Nam.
- Customer centricity
- Collaboration & network, including above affiliate and company networking
- Empowered & accountable
- Experimenting & taking risks
- Growth mindset
5. Expertise and Qualifications
- Knowledge
- Medical/scientific of relevant Therapeutic area/disease
- Knowledge of ICH, GCP and local regulations.
- Knowledge of drug discovery & commercialization processes.
- MS office literate.
- Fluent English language knowledge, written and verbal
- Education/ Qualifications
- Medical degrees are required.
- Any other degrees are advanced
6. Experiences
- Professional experience within the pharmaceutical industry is desirable.
- Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations.
- Experience in development and implementation of clinical trials.
- Experience in the principles and techniques of data analysis, interpretation, and clinical relevance.
- Experience of delivery of scientific presentations.
- Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred
- People management preferred
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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