Job Description

POSITION SUMMARY This position is responsible for managing the HEPZATO KIT REMS program, including the REMS Coordinating Center, and for ensuring the preparation, compilation, distribution and filing of all documentation related to the function of the REMS Coordinating Center, contributing to the communication of all materials related to the operations of the REMS Coordinating Center and ensuring that the HEPZATO KIT REMS goals are met. This position is also responsible for assisting in the coordination of medical affairs projects at the discretion of the Senior Vice President of Clinical Development and Medical Affairs within a project team environment ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. •Manages the HEPZATO KIT REMS program and the HEPZATO KIT REMS Coordinating Center, assures that all incoming forms are processed accurately, in a timely manner, and in accordance with relevant SOPs and FDA-agreed documents, assures that product shipments are approved by the REMS Coordinating Center in accordance with relevant SOPs and FDA-agreed documents, communicates cross-functionally to ensure that relevant stakeholders are kept informed of REMS operations •Coordinates with Quality assurance to ensure productive audits, and responds to audit findings or other findings of non-compliance in order to continually improve REMS operations •Provides REMS training to internal Delcath team members and to external stakeholders as part of the REMS-required training program •Coordinates the preparation and submission of regular REMS Assessments with other members of the Project Team, ensuring that relevant information and activities are performed as outlined in FDA-agreed documents •Coordinates documentation by working with the other members of the Project and Study Teams, assures that all critical documentation pertaining to medical affairs is tracked, distributed, and filed according to Standard Operating Procedures (SOPs) and regulatory guidelines set forth by FDA; by attending Project and Study Team meetings and managing critical documents such as agendas, slides, presentations, and minutes; by supporting and tracking development of key opinion leaders; by supporting and tracking development of safety data and publications; ; by reviewing data and documents for submission to regulatory agencies; by supporting and tracking development of budget proposals and invoices for assigned projects, reviewing and updating system with invoices for approval, and by performing other tasks as requested by the Supervisor. •Provides Medical Affairs Support by serving as a key resource to all members of the Project and Study Teams ,both internal and external; by administering and tracking medical and clinical trial data for assigned Studies and by performing other tasks as requested by the Supervisor. •Coordinates documentation of safety events. Assists in tracking, review and finalization of safety documents. •Performs coordination with medical and clinical vendors by attending regularly scheduled study team meetings; following up on action items, as necessary; by providing feedback, as necessary to vendor staff; by escalating issues, as appropriate; and by performing other tasks as requested by the Supervisor. •Complies with Regulations by following all Company procedures to ensure compliance with FDA, GCP, and ICH regulations, federal and state laws, related statutes, and SOPs; and by advising the study team as necessary on matters affecting project success. •Executes all above mentioned task independently and with oversight from management. As well as; Develops tracking and more efficient tools for medical affairs projects Work closely with cross functional business groups to develop key essential documents and metrics needed Tracking, filing and maintenance of safety files Propose business processes and operating processes to improve trial management •Other tasks may be assigned at the discretion of the Supervisor. SUPERVISORY RESPONSIBILITIES This position is responsible for supervising the Senior REMS Coordinator and any other members of the REMS Coordinating Center. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE •Minimum education requirements: Bachelors degree •Experience required: 3 - 5 Years at CRO or Sponsor-company •Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in pharmaceutical business and elementary scientific technical terms with vendors, consultants, and peers in English. •Ability to read and write study or project updates, minutes, agendas, and other study or project related documents in English. •Ability to effectively present information to and respond to questions from the study team and project-related vendors in English. •Possess a general understanding of the scientific principles used in clinical development process. •Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. •Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists. •Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams. •Computer skills needed include strong knowledge of database and word processing: Outlook, MS Word, PowerPoint, and Excel. Basic use of MS Projects. •Must have a general understanding of clinical trial methodology. •Must have demonstrated ability to work independently, manage time effectively, and handle multiple work pressures. •Must have experience interfacing and managing multiple vendors/contractors. LANGUAGE SKILLS Ability to read and interpret documents such as medical journals, technical journals, safety rules and regulations, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organization MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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