Established Products (EP) Squad APAC is a new model that will feature a location-agnostic squad comprised of members from affiliates throughout the APAC region. They will assume responsibility for the overarching management of EP brands in participating countries. The squad will feature members across various functions such as Medical, Marketing, Strategic Alliance, Regulatory, Supply Chain and more.
The members of the EP Squad will have the opportunity to work in an exciting new cross-border roles created, providing the opportunity to take on above-market work without the need to relocate. This is a unique chance to shape a new business-operating model, and work in a self-organized squad -- fully empowered to shape the outcome. Having an EP Squad above country, allows the participating Affiliate to focus on their Strategic products portfolio as more and more products will fall into the category of Established products.
This position is responsible for Malaysia, Vietnam, South Korea and Philippines and can be based is any of these locations.
A strategic leadership role requiring therapeutic area expertise and clear business understanding to identify and address the relevant medical needs of clinical practice, and successfully support the optimal use of Roche established products.
Links affiliate to the Pharma International and Global Medical Affairs objectives to deliver on data generation, knowledge exchange/data communications, and to lead Therapeutic Area Expert (TAE) engagement in a scientific manner.
Acts as a guardian for high standards of compliance, ethics, and safety of Roche products, putting patients at the center of his/her actions.
Establish long-term, peer-to-peer partnerships with TAEs and investigators in a given therapeutic field and deliver quality interactions and services that bring value to physicians, and align with Roche strategies.
Member of the EP Squad involved in the optimization and expansion of the established products portfolio, implementation of medical strategies and action plans within his/her competencies
Responsible for providing overall strategy and implementation from a Medical and Patient perspective to achieve the EP Squad overall goals, incorporating input and insights from the customers across the healthcare ecosystem and partners across the affiliates.
Required to collaborate with both internal and external cross-functional EP Squad team members, as well as with external stakeholders.
All Roche employees are expected to practice high standards of compliance with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company.
Development of the multi-country medical strategy, consistent with the overall goals and vision of the EP squad.
Generate insights based on the broad and deep understanding in the therapeutic area (treatment landscape, clinical unmet needs, patient journey, market dynamics)
Lead the TAE engagement planning and implementation to support medical objectives: identification, development, and establishment of scientific partnerships across all stakeholders in the healthcare ecosystem.
Providing medical expertise and customer insights to the EP product portfolio.
Delivering scientifically accurate, objective, current and consistent responses to unsolicited product enquiries.
Design, oversight of execution, and report of clinical trials according to ICH-GCP, Roche SOPs and local regulations.
Development of effective interactions with Clinical Operations, including but not limited to placing studies, provide input on feasibility, sites and investigators selection.
Support for Pharmacovigilance activities, including assurance of appropriate adverse event reporting in coordination with Local Safety Responsible.
Support for Regulatory and Medical Information activities for established products.
Medical and regulatory clearance of promotional and informational materials.
Interact with HCPs and Healthcare System stakeholders across countries to understand their views, interests and opportunities, where Roche can collaborate with them to meet their needs aligned with our strategies.
Providing medical expertise to customers, and customer insights to internal stakeholders.
Ensuring logging and tracking of all MI enquiries based on regional guidance.
Compliance and Ethical Standards:
Identifying, collecting and reporting any AE and/or other reportable event and forwarding to the drug safety department within timelines described in relevant SOPs.
Identifying and reporting any product quality complaints and forwarding it to local complaint managers in affiliates within timelines described in relevant SOPs.
Ensuring integrity and scientific accuracy of the MI responses if applicable.
Ensuring copyright compliance for documents provided to the customer if applicable.
Maintain a customer-centric culture, making sure promotional/medical/scientific communications address HCP needs and optimize patient benefit and safety while keeping a fair balance and compliance with regulations and SOPs.
Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing labeling and packaging language, etc.
Medical Value and Leadership:
Maintain the highest standards and levels of scientific and clinical knowledge across therapeutic areas in the established products portfolio.
Offer expert opinion aligned with global medical recommendations on scientific medical information to identify and develop effective peer-to-peer relationships to execute our product strategies, while holding high ethical standards, compliance to Roche SOP and local/international regulations.
Lead development and implementation of communications strategies to support existing and concluded studies. Includes TAE interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials.
Research, collate, present and offer data insights related to the dedicated disease area and product(s).
Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
Manage the Medical Information activities on Roche products to external and internal customers in a timely manner, and meeting local requirements and referencing global standard responses.
Manage publication related activities according to Roche Policy and SOPs.
Stay abreast of internal and external developments, trends and other dynamics relevant to the EP squad, to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
Initiates and develops cross-functional projects, programs or other initiatives that can carry broad and important impact to multiple healthcare systems across different countries.
Development and management of the multi-country medical strategy:
Identify local data gaps, local studies protocol design, study planning (including budget), input to site selection and feasibility assessment, data dissemination strategy.
Align the local medical plan with the local marketing, and global medical plan
Co-lead ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources as needed by the squad.
Engage with HCPs and Healthcare System Partners to understand their views, preferences and interests, where Roche can collaborate with them to meet their needs aligned with our strategies
Gain in-depth understanding of and map practices, needs, preferences and views of new data in collaboration with other functions and across countries.
Communicates with health authorities, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of Roche and patients.
Develop and strengthen strategic partnerships for evidence generation initiatives.
Establish and maintain external stakeholder roadmap in collaboration with other functions and across the network to facilitate scientific exchange and faster access to innovation.
Data Generation and Clinical Trial Operations:
Provide early insights on data gaps across countries for real world evidence generation activities and new indications
Support site feasibility assessments, site development plan, recruitment, retention of patients enrolled in trials and enhancement of site management.
Acquire investigators, patient groups, academe, healthcare authorities and other relevant external stakeholder perspectives of data gaps and clinical studies.
Respond to unsolicited questions from HCPs in accordance with APAC and local laws, regulations and codes and Roche SOPs, facilitate their needs of up to date scientific data, including but not limited to publications of clinical trials, treatment guidelines, by ensuring they have the best quality available information they require.
Ensure scientific exchange and communication towards external experts / TAEs are harmonized across APAC.
Lead sharing Best Practices across customers to facilitate improved patients’ outcomes within and beyond APAC.
Support regulatory activities, including preparation of relevant data for new products/indications’ application and label updates.
Provide medical/scientific support and training for internal staff.
Support and collaborative work with Access, Policy and Communication department, especially the pharmaco-economic, patient advocacy group and government stakeholder team, providing relevant efficacy and safety data on dedicated products.
Support on the information escalation and awareness via other digital platforms such as social media etc.
Co-lead the overarching digital innovation strategy, value proposition and plan, and support its implementation across countries.
Any other duties assigned from time to time as required by the business.
Competencies and Expertise
Leadership competencies: growth mindset, entrepreneurship and ability to drive the delivery of commitment in a matrix team.
Strategic agility: Address the evolving needs from internal/external stakeholders to deliver optimal results.
Analytical Skills: With the knowledge of data analysis and statistics, rich insights based on data from product team and stakeholders
Communication, interpersonal and networking skills: ability to influence without authority and cultivate relationships with internal & external partners/stakeholders at more than one level who may have different interests or goals to reach consensus and achieve team objectives.
Results orientation: take the initiative to drive results and achieve expected outcomes.
Ability to motivate the squad members working towards shared goals
High level of interest in keeping up-to-date with digital technologies - to explore integrated digital solutions such as applications, web-based interactions, etc.
Attention to detail / Meticulous with an eye for detail.
Knowledge of relevant therapeutic areas, ICH, GCP and local regulations.
Knowledge of drug discovery & commercialization processes.
MS office literate.
Fluent English/Local language knowledge, written and verbal
Professional experience of more than 5 years’ of experience in medical affairs or related therapeutic areas 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.
Established network and partnerships with TAEs, other thought leaders, and external organizations are strongly preferred.
Education / Qualifications:
Medical or PhD/PharmD degrees preferred.
Other graduate health science degrees, or equivalent with strong proven therapeutic area experience considered (country specific depending on talent pool).