INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post: Associate Director- SSU Regulatory
Responsibilities
•Oversees and approves courses action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. Supports team managers on all administrative or departmental activities.
•Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned. Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Serves as a departmental point of escalation for internal and external customers.
•Supports management with site start-up and financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Guarantees SSU delivery of assigned projects.
•Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams. •Interacts with internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group. Identifies and reports on areas of process and contract risk.
•Oversees the implementation of customer-required and enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager; may supervise a systems administrator. Develops requirements for modifications to existing systems and reports based on input from functional teams. Provides input and requirements for long-range IT plans. Implements Company and customer-required project management systems and processes.
•Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times. Oversees all quality control efforts of individual departmental teams.
•Represents the Company at professional meetings or seminars.
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Qualifications Requirements :
•Bachelor Degree in Pharmacy, other health-related area, or equivalent combination of education and experience.
•Moderate experience in a CRO and related contract management or site start-up experience.
•Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
•Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Additional Information:
Qualification: Bachelor Degree in Pharmacy
Location: Gurgaon
Industry Type: Pharma
Functional Area: CRO
Last date: 15th August, 2016
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