Clinical Scientific Expert

3 weeks ago

Hyderabad, India Novartis Full time

“150 Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.”
- Your responsibilities include, but are not limited to:
- Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT)
- Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
- In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
- Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
- May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
- May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
- Produce training materials and provide training to iCTT.

**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**
- Minimum requirements:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable. Fluent English (oral and written).
- 1 year experience in pharmaceutical industry/ clinical research organization - Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
- Work experience in clinical operations preferable. Strong interpersonal skills - Ability to work under pressure
- Good negotiation and conflict resolution skills - Collaborates across boundaries for shared success - Resolve issues with mínimal supervision and understands when to escalate - Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process - Strong analytical / computational background - Demonstrates strong Medical / scientific writing skills.

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**
- Global Drug Development

**Business Unit**
- GDO GDD

**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

  • Associate Medical Expert

    4 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...

  • Scientific/medical Writer

    4 weeks ago

    Hyderabad, India Covi-Sense Full time

    Salary: 5 to 6 Lacks **Position Description**: Content development/medical writing team is responsible for developing high quality scientific/medical content which could be used by our customers for their scientific /promotional activities. The content team will customize the content as per tactic which include, but not limited to: slides/slide updates for...

  • Clinical Project Coordinator

    4 weeks ago

    Hyderabad, India Makrocare Full time

    Company Description **MakroCare |** **_A MakroGroup Company_**MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...

  • Scientific Writer II

    7 days ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Expert Regulatory Writer

    4 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...

  • Clinical Research Coordinator

    4 weeks ago

    Hyderabad, India Fusion Market Research Full time

    Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem...

  • Senior Scientific Writer I

    7 days ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Senior Expert Science

    1 week ago

    hyderabad, India Novartis Full time

    400! This is the number of associates in Global Analytical R&D, across 4 countries, working tirelessly on innovative and patient centric medicines. As part of this group, you design, plan and/or perform scientific/technical studies. By bridging the analytical science to the clinical performance you will drive the transformation of our molecules into...

  • TCO Physician

    1 day ago

    hyderabad, India Novartis Full time

    Your responsibilities include, but are not limited to:•Provides scientific and medical expertise on assigned clinical projects. Contributes to clinical strategy for the Asian region.•Accountable for all aspects related to wind down projects including review of clinical data, and oversight of all CSR related activities.•Contributes to clinical trial...

  • Medical Scientific Liaison: Hyderabad

    3 days ago

    hyderabad, India 703 GlaxoSmithKline Pharmaceuticals Limited Full time

    Medical Scientific Liaison – Adult Vaccines (Hyderabad) Job Responsibilities: Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with...

  • Medical Scientific Liaison: Hyderabad

    4 days ago

    Hyderabad, India 703 GlaxoSmithKline Pharmaceuticals Limited Full time

    Medical Scientific Liaison – Adult Vaccines (Hyderabad) Job Responsibilities: Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with...

  • Expert Science

    4 weeks ago

    Hyderabad, India Novartis Full time

    400! This is the number of associates in Global Analytical R&D, across 4 countries, working tirelessly on innovative and patient centric medicines. As part of this group, you design, plan and/or perform scientific/technical studies. By bridging the analytical science to the clinical performance you will drive the transformation of our molecules into...

  • Clinical Data Specialist

    4 weeks ago

    hyderabad, India Novartis Full time

    Your responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and updated...

  • Clinical Data Manager

    2 weeks ago

    Hyderabad, India EMentor Enterprises Private Limited Full time

    Position: Clinical DataManagerRequirement: ImmediateJoinerLocation:HyderabadExperience: 3 to 10Years Key Roles &Responsibilities:Provide leadership and vision tothe team.Manage and deliver largescalehighcomplexity studies across a range of sponsors and therapeuticareas.Manage sponsors at both the study andprogram levels.Ensure milestones meettimelines and...

  • Clinical Data Specialist

    2 weeks ago

    Hyderabad, India Lifelancer Full time

    About The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and...

  • Clinical Data Specialist

    2 weeks ago

    hyderabad, India Lifelancer Full time

    About The Role Your responsibilities include, but are not limited to: Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol. Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new...

  • Vendor Category Expert FSP

    5 hours ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   We are currently looking for a Vendor Category Expert to join Parexel FSP Department The successful candidate will have: Knowledge and Experience: • 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management • Excellent knowledge...

  • Vendor Category Expert Fsp

    4 hours ago

    Hyderabad, Telangana, India Parexel Full time

    Hyderabad, Telangana, India **Job ID** R0000023131 **Category** Clinical Trials **ABOUT THIS ROLE**: We are currently looking for a Vendor Category Expert to join Parexel FSP Department Knowledge and Experience: - 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management - Excellent knowledge of GxP and...

  • Vendor Category Expert FSP

    4 hours ago

    Hyderabad, Telangana, India Parexel Full time

    We are currently looking for a Vendor Category Expert to join Parexel FSP DepartmentThe successful candidate will have:Knowledge and Experience: 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management Excellent knowledge of GxP and ICH regulations Expert knowledge of clinical trial design and mapping to...

  • CAD Leader

    3 days ago

    Hyderabad, India Thermo Fisher Scientific Full time

    :Collaborate with industrial designers builds from concept to product by crafting CAD from sketches or translating surfacing models using SolidWorks software.Expert in SolidWorks tool and guide the other team on SolidWorks modelling and drawing development.Works a quality checker for drawings and ensure the change history, BOM , Engineering change documents...