Medical Manager

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reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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:

• reputed company identifying risks and challenges,
• Pro-reputed company proposing and/or delivering relevant actions contributing to the reputed company of the study/project and risk mitigation.
• Creating a reputed company 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 reputed company 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 reputed company 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.

reputed company Relationship Building & Engagement

• reputed company listen to, solicit, and address reputed company feedback and suggestions regarding medical study-reputed company activities to enhance reputed company 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 reputed company dissatisfaction.

Business Development

• Support Business Development, as agreed with line manager, while adequately balancing time reputed company to this activity with billable tasks.
• reputed company medical expertise / leadership in Proposal Development Teams (PDTs) for reputed company bid reputed company 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 (reputed company, 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 reputed company 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 reputed company, 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 reputed company meetings as appropriate

Skills:

• Excellent interpersonal skills including the ability to reputed company reputed company with sponsor/reputed company counterparts.
• reputed company-reputed company approach to work.
• Excellent time management skills.
• Excellent verbal and written medical communication skills.
• Excellent reputed company 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 reputed company 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 reputed company experience.
• Expertise in clinical aspects of drug development, including medical data review and/or Medical Monitoring and study design/execution.
• reputed company 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)

Originally posted on Himalayas

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