Clinical Research Medical Advisor

2 months ago

Mumbai, India Novartis Full time

105,000 people reimagining medicine for more than 766 million people globally. To provide country clinical strategic guidance and feasibility assessment for GDD trials.
Your responsibilities include, but are not limited to
- To provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical program documents as needed. To provide country clinical strategic guidance and feasibility assessment for GDD trials. Closely collaborates with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan
- May lead medical/clinical discussion with local regulatory interactions as needed (CTA, NDA meetings, label discussions, post-approval commitments etc.). Cooperates with local functions such as e.g. Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project(s) in the context of the investigational product(s).
- Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines: Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
- Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed, provide protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness. Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feedback, etc.) and analysis of the competitive environment, Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions
- Review country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the local language, including the patient narrative where appropriate, Support Ministry of Health interaction (or local Board of Health) as required, Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials.
- Support planning, implementation and follow-up of regulatory agency inspections and internal audits, Review and try to resolve local medical issues / questions and, if feasible, support TMO with recruitment/ operational issues that arise during the entire course of the study - if necessary, support the discussion of issues to global teams. Perform local AE review for development compounds and provide general medical support for safety issues: Provide medical expertise support to pharmacovigilance activities, responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed, follow-up with the Investigator for additional information or clarifications as needed, When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
- May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as CO representative in Regional/Global team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment, Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations, Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional CO strategy, Participate in global working groups in order to support and improve processes for the CD&A/CRMA Line function

**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**

WHAT YOU’LL BRING TO THE ROLE:

- Scientific degree (medical degree highly desirable, 40 % of CRMA FTEs in a country if possible).
- Trained in relevant aspects of clinical drug development incl

  • Clinical Research Medical Advisor

    1 month ago

    Mumbai, Maharashtra, India Novartis Full time

    393172BR **Clinical Research Medical Advisor**: India **About the role** Novartis is a pioneer in drug development with a robust pipeline across therapy areas. CRMAs work closely with Investigators and ensure scientific engagement with the Investigator community to drive our programs and trials across the globe. Your responsibilities include, but are not...

  • Area Medical Advisor

    2 months ago

    mumbai, India Pfizer Full time

    Provide scientific expertise, build knowledge and activity based relationships with Key Opinion Leaders to advance medical practice and research for the benefit of the society, thus enhancing Pfizer’s image in the scientific community. To actively contribute to the organization/business by taking responsibility for the scientific, technical and ethical...

  • Area Medical Advisor

    2 months ago

    Mumbai, India Pfizer Full time

    Provide scientific expertise, build knowledge and activity based relationships with Key Opinion Leaders to advance medical practice and research for the benefit of the society, thus enhancing Pfizer’s image in the scientific community. To actively contribute to the organization/business by taking responsibility for the scientific, technical and ethical...

  • Regional Medical Advisor

    2 weeks ago

    mumbai, India Abbott Full time

    This position typically refers to any employee within the EPD Medical organization with medical/scientific qualifications and training who provides scientific/medical support to EPD in a non-sales capacity, where the provision of such scientific/medical support includes significant contact with Abbott customers in the field. This definition is not...

  • Regional Medical Advisor

    2 weeks ago

    Mumbai, India Abbott Full time

    This position typically refers to any employee within the EPD Medical organization with medical/scientific qualifications and training who provides scientific/medical support to EPD in a non-sales capacity, where the provision of such scientific/medical support includes significant contact with Abbott customers in the field. This definition is not...

  • Medical Advisor

    1 month ago

    Mumbai, India Pfizer Full time

    MAIN REPONSIBILITIES / DUTIES - Medical Strategy Development /Policy shaping - To develop and lead the implementation of the medical strategy for the Business Unit (BU) across diverse therapeutic areas. - Provide medical support towards business development and new product launches. Will be ultimately accountable for the medical and regulatory strategy to...

  • Regional Medical Advisor

    1 month ago

    Mumbai, Maharashtra, India Abbott Laboratories Full time

    Reporting into the Senior Manager RMA / Head RMA this position participates in the initiation, oversight and follow-up of assigned clinical studies and medical projects initiated within the EPD Medical Organization, ensuring that activities are carried out in accordance with relevant processes and procedures. The RMA interfaces with other key members of the...

  • Clinical Research Associate

    2 weeks ago

    Mumbai, Maharashtra, India Novartis Full time

    **Summary**: Monitors patient data & study-related information related to clinical study sites and clinical trial participation.. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related...

  • Medical Advisor

    1 month ago

    Mumbai, Maharashtra, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Medical Advisor - EM**: - Date: Apr 2, 2024- Location: Sun House - Corporate Office- Company: Sun Pharmaceutical Industries Ltd**Job Title**: **Medical Advisor **Job Category**: Head Office Based Medical Affairs **Department**: Medical Affairs **Qualification** MBBS with M.D. Pharmacology/Medicine or full time post-graduate qualification of at...

  • Medical Advisor

    1 month ago

    Mumbai, Maharashtra, India Sun Pharmaceutical Industries Ltd Full time

    **Job Title**: **Medical Advisor **Job Category**: Head Office Based Medical Affairs **Department**: Medical Affairs **Qualification** MBBS with M.D. Pharmacology/Medicine or full time post-graduate qualification of at least 2-years’ duration in any discipline of medicine **Location**: Mumbai **Travel Required**: Yes **Reporting to**: GM Medical...

  • Medical Advisor

    1 month ago

    Mumbai, India Johnson & Johnson Full time

    **Recruiter: Reepa Sarda Pal** **Medical Advisor, Metabolics** **Mumbai, India** Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than...

  • Medical Advisor, Hospital Bu

    1 month ago

    Mumbai, India Pfizer Full time

    Medical Strategy Development /Policy shaping - To develop and lead the implementation of the medical strategy for the Hospital Business Unit (HBU) - Provide medical support towards business development, new product launches, and stewardship initiatives. Will be ultimately accountable for the medical and regulatory strategy to support BD and new launches for...

  • Medical Advisor

    1 month ago

    Mumbai, India Elevation HR LLP Full time

    **JOB PURPOSE** To assist clinical research teams and often help training and supporting the sales force. To provide an authoritative opinion regarding medical based questions, legal and regulatory matters thus enabling colleagues to comply with the required statutory requirements. **PRINCIPAL ACCOUNTABILITIES** - Scrutiny of files to determine if the...

  • Medical Advisor

    3 weeks ago

    mumbai, India Abbott Full time

    • Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature. • Provide expert medical/scientific advice for assigned products and...

  • Regional Medical Advisor

    2 weeks ago

    Mumbai, India Novo Nordisk AS Full time

    Location - Mumbai  Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? Apply now with your latest profile and you may be our new Regional Medical Advisor. The Position As a...

  • Regional Medical Advisor

    2 weeks ago

    mumbai, India Novo Nordisk AS Full time

    Location - Mumbai  Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? Apply now with your latest profile and you may be our new Regional Medical Advisor. The Position As...

  • Medical Advisor

    2 months ago

    Mumbai, India Abbott Full time

    Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature. • Provide expert medical/scientific advice for assigned products and related...

  • Medical Advisor

    2 months ago

    Mumbai, India Abbott Laboratories Full time

    Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature.• Provide expert medical/scientific advice for assigned products and related...

  • Medical Advisor

    11 hours ago

    Mumbai, India Abbott Laboratories Full time

    • Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature. • Provide expert medical/scientific advice for assigned products and...

  • Medical Advisor

    1 month ago

    Mumbai, Maharashtra, India Abbott Laboratories Full time

    Develop and maintain in-depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance/ participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature. - Provide expert medical/scientific advice for assigned products and related...