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Novartis Pharmaceuticals TCO Medical Expert/Group Lead in Hyderabad, AP, India

380993BR Job ID: 380993BR Job Description: Your responsibilities include, but are not limited to: • Responsible for building the TCO India organization in accordance with the strategic vision for TCO in India. Leads the TCO India team. Contributes to talent and career development of TCO team locally. In collaboration with the relevant functional TCO manager, contributes to the hiring/interview/onboarding and mentoring process for new hires in India. • Acts as medical expert/lead for TCO studies managed by clinical operations in India, with oversight of TCO deliverables. Provides scientific and medical expertise on assigned clinical projects. Represents TCO at project team meetings, inputs to project strategy. Oversees the clinical/scientific elements of TCO – related submission documents. Including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc. • Leads the ongoing clinical trial data medical/scientific review across assigned TCO projects and coordinates data analysis and interpretation including the development of first interpretable results, clinical study report, publications, and internal/external presentations. • Accountable for Clinical Study Report review, consistency, quality, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team. • Identifies and implements process improvements. Responsible for the implementation of best practices and standards for trial management within TCO, including sharing lessons learned. • Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India • Advocate continuous improvement of quality, Ensure all activities of associates comply with company standards and local regulations. • Ensure adequate reporting of adverse events/technical complaints/compliance issues in accordance with company procedures. 100% timely delivery of training requirements including compliance \n\n\n\n Position Title: TCO Medical Expert/Group Lead Minimum requirements: • 8 years of pharmaceutical/biotech industry experience, Experience with oncology trials, early development trials. Extensive knowledge of Good Clinical Practice. • Demonstrated leadership and people management and mentoring skills. • Strong operational project and management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. • Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects. • Strategic thinking: ability to network with and influence opinion leaders, clear and logical presentation of complex strategic issues. • Clear written and verbal expression of ideas, an active/proactive communicator. Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with and influencing with a wide range of people, building strong positive relationships. • Elevated level of customer orientation awareness and focus. Used to working independently and in a team, being flexible and adapting in a changing environment. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: Novartis Institutes for BioMedical Research Business Unit: Translational Medicine Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No