Therapy Area Medical Expert

Job Description

Pan-India accountabilities for disease area (Approx. 70%):

• Deep disease area expertise: Custodian of assigned TA data, ensure credible scientific communication dissemination
• Support development and execution of patient-focused medical strategies that supports to maximize the value proposition of assigned Roche therapies including support in annual strategic planning, launch support by participating in Launch squads and lifecycle management, in collaboration with appropriate cross-functional teams and governance
• Determine scientific/medical subject matter appropriateness of labels/regulatory/patient access/promotional material and medical deliverables (eg , slide decks, publications, educational activities, any other TA relevant medical contents) used to support internal/external interactions through appropriate review process as per SOPs
• Synthesize and integrate insights to deliver medical inputs into relevant cross-regional/functional strategies, including relevant brand strategy
• Foster and enhance collaboration and coordination across Medical Teams in India
• Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
• Lead/support relationships with external healthcare community, including interactions with Top TAEs, payers and societies for scientific exchange, where appropriate
• Develop and lead evidence generation projects (clinical protocols, RWE, digital, registries)
• Design medical activities & solutions (E.g. clinical ecosystem initiatives, Advisory Boards, digital solutions)
• Respond to unsolicited queries for the assigned TA from HCPs in accordance to local laws, regulations and codes and Roche SOPs, facilitate their needs of up to date scientific data.
• Ensure product/disease state/pipeline specific medical training where appropriate
• Support to the Regulatory Teams by providing medical expertise for New Product / Indications dossier review, SEC Preparation and presentation support to Global Team and Local RA from medical aspects. Review and approval of Prescribing information and Abridged prescribing information for the assigned Brands
• Clinical Operations Team - Facilitates Investigator Initiated Studies through review of Study materials. Support for initial investigator /site mapping for the PDMA studies. Scientific responsible for clinical studies in the affiliate.
• Medical support for CU program for Review of case details on PAIRS system and coordination with the treating Physicians as appropriate.
• Responsible & Accountable for preparing the budget of the assigned therapy area medical activities and adherence to assigned budget as per Roche guidelines.
• Leverage Global network for solutions and best practices by participating in Community of interest / CoP and be Global point of contact for the assigned TA
• Provide decision on IME, Donations, medical grants and sponsorships, where appropriate
• Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
• Foster Roche s reputation as a science-based, innovative and patient-focused reliable partner

Cluster level accountabilities (Approx. 30%):

• Support cluster teams in driving belief shift for Roche innovation through interactions with & customizing solutions for Top TAEs
• Support Cluster teams in driving belief shift for Roche innovation, including value of innovations vs NCBs
• Support overall medical strategy for the clusters
• Act as VACC leader for the Medical Engagement Partners of the cluster
• Generalist for any Medical need for the clusters
• Provide direct deep expertise in his TA to the clusters

Qualification: Medical Degree required - MBBS, MD / DNB (Any Specialization) is a mustMD Radiation, Any Disease relevant Medical Education, Clinical Oncology Degree will be preferred.Experience

• Professional experience of minimum 6 yrs within the Medical affairs of pharmaceutical industry is a must
• Current Oncology experience is a must, Experience in relevant therapeutic area strongly preferred
• Overall experience of more than 9 years including clinical experience is preferred.
• Experience in local medical practice and healthcare ecosystems
• Skilled at engagement, scientific exchange with external medical community
• Experience of Pharmaceutical product development, product lifecycle and commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, Strategy and Medical Affairs
• Experience in product launches
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Sound scientific and clinical judgement
• Knowledge of Good Clinical Practices (GCP), local regulations and guidelines, and applicable regulatory requirements
• Familiarity of local pharmaceutical industry and legal/health system environment
• Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Network of Top TAEs, other thought leaders, and external professional, disease, and research organizations in product/therapeutic area
• Experience in delivery of scientific presentations
• Project management ability & Proven experience in working with multidisciplinary teams
• Fluent English & national language knowledge, written and verbal
• Willingness to relocate

Roche is an equal opportunity employer.Medical Affairs, Medical Affairs > Medical Information/Scientific Affairs,

Keyskills :
slide deckslaunch supportmedical affairsadvisory boardstherapeutic areamedical trainingclinical researchmedical educationstrategic planningclinical practicesproduct development