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Job Location | Mumbai City |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Hospital Management / DirectorSBU Head / CEO / Director |
EmploymentType | Full-time |
Ensure that the medical team is inspired to contribute towards transforming the clinical practice & healthcare thereby serving the patients and contributing to the Citizen well- being. The role also ensures Roche vision is lived by teams and ensures high quality standards and compliance to regulations thereby ensuring license to operate. Role also supports the health system transformation and Health policies. Participate in formulating the yearly and long- term strategy and purpose of the organization to ensure its alignment with the overall Roche s global vision Strategize and guide the identification of new opportunities, continuous product / disease tracking and provide inputs on optimizing the product portfolio for the region; maintain up- to- date knowledge of new products in the market and their areas of application, new diseases and possible cures to leverage existing products in new markets or to introduce new products. Guide the clinical operations team in strategizing its reporting process including setting up a framework, planning and tracking the study, defining the budget requirements to operationalize the trials in association with hospitals while ensuring compliance to all statutory provisions, quality standards in line with company s global guidelines Guide the regulatory team in creating the strategy for getting the new and subsequent drug approvals, identifying waiver criteria, maintaining licenses and regulatory compliance; direct quality assurance initiatives to maintain drug quality during drug transportation Inspire the stakeholders (like MoH, DCGI, Key KOLs, Medical & Patient associations) by sharing the best practices, harmonizing the standards to bring more clinical trials in India and innovative solutions faster to Indian citizens Guide and assist the Drug safety team in setting up guidelines and SOPs to maintain highest level of compliance Guide and assist the Local Quality Responsible and oversee the implementation of quality management system within the organization to ensure the country compliances are followed and corrective measures are taken. Functional Competencies Knowledge of healthcare landscape People management Multiple therapy area knowledge Technical expertise in field of Medical affairs, clinical operations, drug safety and related regulatory aspects. Change management Behavioral Competencies Exhibition of Roche Leadership Commitments and Roche Core Values Exhibition of Quantum self Patient centricity in decision making Strong Collaboration and Networking skills Inspiring and Influencing Relevant Experience: Having a Medical Degree with minimum 12 years in the Industry (Pharmaceutical / Biotech) with an overall experience in medical affairs and clinical operations function.Roche is an equal opportunity employer. Medical Affairs, Medical Affairs > Medical Information /Scientific Affairs,
Keyskills :
businessdevelopment marketing insurance highqualitystandards qualitymanagementsystem drugsafety clinicaltrials medicalaffairs qualityassurance changemanagement peoplemanagement etw king macromediadirect