Medical Expert

Job Description

Major accountabilities:

- Provides medical support to Clinical Program Leader (CPL) leading the program. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables.
- May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team.
- May represents CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy
- May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits.
- 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 studies and coordinates data analysis and interpretation
- Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team
- Manages stakeholder engagements internally and externally
- Mentors and coaches junior TCO team members in India
- 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

Key performance indicators:

- Management of assigned studies to ensure execution according to timelines, and with high quality, ensuring adherence to international and local regulations.
- Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents.
- Strong evidence of quality medical review of trial data and quality contributions to clinical sections of e.g. protocols, IBs, DSURs and CSRs
- Contribution towards objectives set for the department.
- Feedback from external and internal stakeholders.
- Clearly demonstrates Novartis Values and Behaviors.

Minimum Requirements:

Education:

- MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.
- Experience in hematology / oncology preferred

Work Experience:

- At least 5 years of pharmaceutical/biotech industry experience
- At least 2 years of clinical practice experience in the hospital setting.
- Experience with oncology clinical trials
- Experience with early development clinical trials
- Knowledge of Good Clinical Practice (GCP).
- Strong operational project 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 key stakeholders, 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, influencing and building strong positive relationships.
- Used to working independently and in a team, being flexible and adapting in a changing environment.

Skills:

- Clinical Monitoring.
- Clinical Research.
- Clinical Trial Protocol.
- Clinical Trials.
- Decision Making Skills.
- Drug Development.
- Health Sciences.
- Lifesciences.
- Medical Strategy.
- Regulatory Compliance.

Languages :

- English.

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Lifesciences, Medical Strategy, Regulatory Compliance

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