Summary: Under administrative direction, provides medical expertise to assist with clinical product development in the Company’s specific therapeutic focus areas. Directs the clinical project team, and contributes to collaborative efforts with other Company departments, as well as coordinating the involvement of outside consultants and investigators. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not berequired to perform all duties listed, and may be required to perform additional, position-specific tasks. Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. Contributes to the development of project-specific clinical development plans, including, key activities and timing, project costs, resource estimates and critical success factors. Tracks progress towards achieving key objectives. Provides general medical and scientific clinical research expertise in the development of overall strategy and objectives of the Clinical Plan. Assists in preparation and review of project-specific clinical trial designs and associated protocols. Evaluates and assists in preparation of abstract/manuscripts, etc. for presentation/publication at internal/external meetings. Reviews project-specific Investigator Brochures, CRFs, Statistical Analysis Plans and Final Clinical Reports. Represents the Company as medical expert to the medical community and health authorities in support of projects. Offers support/medical expertise for evaluation of new product opportunities and commercialization activities. Presents input on clinical sections and assists in preparation and review of regulatory submissions, responses to FDA requests and pre-meeting packages. Contributes to the drafting of product labeling for review and inclusion in NDA submissions. Establishes performance standards for assigned activities and reviews output to ensure standards are consistently met. Oversees, participates and approves the training of departmental employees; conducts the performance evaluations for direct reports. Provides support, direction and coaching to subordinate employees in the areas of training, disciplinary action, problem resolution, planning and work assignment delegation. Ensures compliance with all Company policies and procedures, including safety rules and regulations. Performs related duties as assigned. Required Knowledge and Skills: Current Good Manufacturing Practices (cGMP), Current Good Clinical Practices (cGCP), Food and Drug Administration (FDA), International Conference on Harmonisation (ICH) and other regulatory requirements. Business, scientific and personal computer hardware and software applications. Current clinical research procedures and practices. Business English usage, spelling, grammar and punctuation. Principles and practices of budget preparation and administration. Administration, supervision and training practices and methods. Current Company policies, practices and procedures, including safety rules and regulations. Skill in: Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources. Responding to sensitive and complex inquiries from management, employees and regulatory agencies. Preparing, presenting and administering budgets and financial reports. Communicating clearly and concisely, both orally and in writing. Operating personal computers. Managing multiple projects, duties and assignments. Interpreting and applying Federal, state and local policies, procedures, laws and regulations. Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel. Establishing and maintaining cooperative working relationships with others. Ensuring compliance with all Company policies and procedures, including safety rules and regulations. Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and occasional business travel. Work is performed in an office environment. Minimum Qualifications: Medical degree (M.D.) in a scientific/technical or related field from an accredited college or university, and six (6) years pharmaceutical/clinical experience, including four (4) years in a supervisory or management capacity or an equivalent combination of education and experience
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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