Clinical Research Physician

2 weeks ago

Bengaluru, India Eli Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- PURPOSE OF THE JOB
- The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
- Core Job Responsibilities
- This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
- The primary responsibilities of the LCCI CRP are generally related to late-phase/end of life cycle of marketed compounds.
- The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
- Regulatory Support Activities_
- Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), DSUR, PSUR/PBRER, label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
- Participate in advisory committees.
- Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
- Scientific I Technical Expertise and continued development_
- Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
- Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
- Responsible for the scientific training of the clinical study team.
- Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
- Explore and take advantage of opportunities for extramural scientific experiences.
- Attend scientific symposia.
- Scientific Data _
- Dissemination/Exchange_
- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
- Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Support medical information associates in preparation and review of medical letters and other medical information materials.
- Prepare or review scientific information in response to customer questions or media requests
- Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
- Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support the design of customer research as medical expert
- Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel.
- Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
-

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