Medical & Scientific Partner

Contenido de trabajo

The PositionResponsible for:

• 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

Key ActivitiesMedical 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

Strategic partnerships

• 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

Knowledge Exchange

• 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

Others

• 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

Who we areAt 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.