Medical Expert

2 weeks ago


Hyderabad, India Novartis Full time

108,000 people reimagining medicine for more than 799 million people globally. Be part of this journey by representing a group that delivers medical communication solutions across multiple franchises, business units and affiliates. Our services and customized solutions enhance the reach of clinical data about relevant therapeutic advancements and supports in right treatment decisions. We support scientific writing, medical communications plan development, innovative ways of evidence dissemination, supporting our colleagues in medical affairs organization.
- Your responsibilities include, but are not limited to:
- Provide scientific and medical input for Medical &Knowledge Solution scientific and medical services strategy.
- Enable excellence in scientific service delivery by strong matrix leadership across Global/Regional M&KS organization and offshore service centres (NGSC).
- Build and maintain a strong business colleague focus and collaboration with NGSCs as well as Global Product Leads and Global Process Owners to represent voice of business colleagues in service development and delivery
- Serve as the T&MO scientific and medical expert in interactions/meetings with Novartis Scientific and Medical organizations and other scientific committees and on business colleague request participate in meetings with external experts/investigators and key opinion leaders.
- Provide scientific and medical expertise during regulatory agency inspections and internal audits for T&MO supported projects.
- Contribute to continuous service improvement initiatives in M&KS. Ensure on-going operational excellence and continuity among scientific services and operations aligned delivery resources
- Serve as Medical Expert/ Scientific Advisor specifically for the following T&MO services: Study Support
- In collaboration with appropriate Clinical Trial Team (CTT) members: ensures direct medical support for assigned interventional and non-interventional studies as needed and may act as medical monitor;
- Contributes to the scientific, medical input and design of assigned protocol(s) within a program or section. Contributes to development of study protocol and regulatory documents - Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities, supports medical review, reporting of quality data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH, and regulatory requirements.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Education
- Minimum MBBS + MD/DM. 10+ years in Clinical Development/Medical Affairs areas with hands on experience in at least two different therapeutic areas.
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies in an international pharmaceutical company.
- Manage several trials in parallel with multidisciplinary trial teams in a matrix organization. Medical expertise appropriate to main therapeutic areas of Novartis
- Demonstrates ability to establish strong scientific partnership with key internal and external stakeholders
- Preferred: experience in remote relationships (on-shore/off-shore capability delivery).
- Significant experience of managing multi-functional scientific and medical projects, transitions, migrations with internal and external stakeholders

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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

**Division**
- Novartis Technical Operations

**Business Unit**
- CONEXTS

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No



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