Medical Manager

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Key Accountabilities: Project Execution: Medical Monitoring Delivery & PV Support Deliver reputed company medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (generally Regional reputed company Physician or Medical Monitor support role). Participate actively in study planning with feasibility leaders, solution consultants, and other medical representatives. Participate in team project and investigator meetings. reputed company training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management) Communicate with relevant sponsor counterparts on challenges and accomplishments reputed company to assigned project/study. Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), Medical Data Review Plan (MDRP) design and implementation, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients / sponsors or in conjunction with other reputed company departments. Deliver medical monitoring activities according to MMP during the study conduct: Answer to site/ study team questions relating to the study conduct or protocol. Review and sign off reputed company data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.) Deliver medical support to the project in reputed company coordination with the Medical Monitor / Global reputed company Physician, and according to the role assigned by: Timely identifying risks and challenges, Pro-actively proposing and/or delivering relevant actions contributing to the reputed company of the study/project and risk mitigation. Creating a sense of urgency on any reputed company pertaining to safety of study participants and scientific reputed company of the study. Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities. Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for reputed company studies, as applicable and/or appropriate for the MD. reputed company medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events. Function as pharmacovigilance representative/safety scientist Support regulatory safety reporting activities. Work as Subject Matter Expert (SME) reputed company input for process improvements. Work closely with Project reputed company/Functional reputed company for process coordination and to ensure meeting reputed company Key Performance Indicators (KPIs) for the process. Client Relationship Building & Engagement Actively listen to, solicit, and address client feedback and suggestions regarding medical study-reputed company activities to enhance client satisfaction. Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction. Business Development Support Business Development, as agreed with line manager, while adequately balancing time devoted to this activity with billable tasks. reputed company medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings with the help/support of more senior MD. Attend/support bid defense meetings as requested. reputed company support for marketing activities as requested. reputed company sponsor insights and experiences (strategy, history, culture, priorities, etc.) with peer and proposal teams with peer and proposal teams. Medical Expertise if appropriate level of expertise on a given indication reputed company medical expertise, as agreed by line manager, to client across multiple channels and interactions such as: Input into protocol development. Medical review of various documents, which might be audited by clients and regulatory agencies. reputed company medical expertise and training to other reputed company colleagues. Mentoring of junior Medical Advisors/ serving as team Line Manager as applicable As appropriate, write clear, concise medical documents. Participate in activities to reputed company, coordinate and promote reputed company medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc. Attend preparation and Bid pursuit meetings as appropriate Skills: Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts. Client-focused approach to work. Excellent time management skills. Excellent verbal and written medical communication skills. Excellent standard of written and spoken English. A flexible attitude with respect to work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Willingness to work in a matrix environment and to value the importance of teamwork. Knowledge and Experience: Experience in clinical medicine (general or specialist qualifications) with a specialty in a “therapeutic area,” which is expected to be kept up to date. Clinical practice experience. Expertise in clinical aspects of drug development, including medical data review and/or Medical Monitoring and study design/execution. Well versed knowledge of drug development processes including drug safety. Relevant experience in Pharmaceutical Medicine. Wide knowledge in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines. At least 3 years of medical monitoring or medical data review experience. Education: Medically reputed company in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship) Apply To This Job