Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
The Medical & License to Operate & Digital Lead roles are part of the country’s enabling team and are the local delegate of authority of Roche’s Pharma Chief Medical Officer. They drive scientific, medical and clinical excellence and innovation through strategic leadership, strong cross-functional work, ensuring superior patient outcomes, medical compliance, and collaborative partnerships, while fostering a high performance culture and continuous professional development aligned with enterprise strategies and outcomes.
Your Responsibilities
- Shared responsibility for the affiliate enterprise strategy setting, short, mid and long term outcome definition, prioritization and adequate resourcing as well as compelling delivery of the agreed business objectives
- Ensure business success through competitive medical strategies whilst maintaining integrity and preserve the company’s reputation, and ensures medical team members work effectively cross-functional for the benefit of the portfolio centered on patients and anchored in our innovation & science
- Establish and maintain highest medical and scientific rigor in all areas and particularly in our current Therapeutic Areas for E2E leadership, and builds scientifically sound medical teams capable of making portfolio differentiating decisions with an E2E perspective
- Ensure appropriate medical and scientific contribution to the development of competitive and differentiating local and global strategies and tactics across the entire life cycle of our portfolio
- Must win countries ensure timely and qualified input to inform and shape global asset and disease strategies which requires adequate staffing and preparation locally and ensure that learning and materials are passed on to subsequent launch wave countries
- Represent Roche and our scientific positions and portfolio as appropriate among key external stakeholders eg. Eco-system stakeholders including politicians, policy makers, scientific partnerships, media interactions, patient advocacy, other pharma companies (individual or association).
- Establish and maintain local medical and scientific independence and assurance of medical compliance acting as the local delegate of authority of Roche`s Pharma CMO ensuring business integrity and company reputation
- Act as local integrator of development and license to operate functions namely safety, regulatory, quality, and clinical operations irrespective of their reporting lines to ensure that development functions work coherently and interactively across and with other local functions, encourage development functions to align as appropriate with global functions, and enable the organization to serve local needs and to cover local accountabilities in line with rules and regulations.
- Accountable for the appropriate approval of non-promotional and promotional materials ensuring compliance with applicable local and global requirements, and ensures medical compliance as the local delegate of authority of Roche`s Pharma CMO. And accountable for the strategic and appropriate use of Grants, Sponsorships and Donations
- Architect, catalyse and coach effective interfaces between medical enablers, safety, quality, regulatory functions and Primary Point of Contact (PPoC) roles to enable fit-for purpose integrated customer-centric solutions with adherence to the highest ethical, compliance and quality standards
- Local integrator of affiliate License to Operate (LTO) functions namely clinical operations, regulatory, quality, safety and if applicable biometrics to ensure that affiliate License to Operate functions work coherently and integratively at local level and to cover local accountabilities in line with rules and regulations
- Ensures appropriate risk assessment and issue management in the LTO or Medical Field via either the Affiliate Medical Compliance Oversight process or via formed fit for purpose cross-functional teams
- Developing Digital Health solutions locally has a high complexity and compliance risks, thus, the Medical & License to Operate and Digital is accountable to ensure adherence to quality standards, rules and regulations considerations of the risks, the portfolio fit and/or desired return of investment rests with the affiliate leadership team
- Accountable for leading and driving the strategic vision for embedding digital inside the organization transforming the actual go-to-market model into a Digital Engagement Model, and leading strategic projects to roll out new digital capabilities and lead the assessments of new technologies
Who You Are
- You hold a University degree in Medicine, or HCPs (e.g. pharmacist) or Human Life Science degree with the relevant experience might be considered
- You have good understanding of pharmaceutical business (Business and financial acumen) with profound Medical Affairs experience, local health care system, including regulatory and payer environment
- You have good understanding of medical and strategic aspects of drug development stages; medical strategies including integrated evidence generation, knowledge sharing and scientific collaborations; medical compliance (GCP/GVP/GMP/GDP), Health Care Compliance and Quality Assurance Management
- You built experience of practicing clinical medicine (if MD) and clinical research is a plus
- should demonstrate a willingness to learn the language rapidly in order to meet job demands.
- You are a servant leader exemplifying VACC leadership, Roche Values, Roche Leadership Commitments and inclusive leadership behaviors; a system thinker with deep listening skills and growth mindset, able to learn and unlearn quickly while experimenting and taking smart risks.
- You are able to manage high complexity balancing people development, competency building and external leadership, and are an enabler to leverage internal and external networks to create and maximize value
- You have excellent oral and written communication skills, including the ability to articulate clear messages from complex data/ information
- You are fluent in English and Romanian languages. If Romanian language is not proficient, candidates
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.
Read Full Description