Regulatory and Start up Specialist in Romania
IQVIA
Voluntari, Romania
5 zile în urmă

PURPOSE

Direct, manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.

Manage Regulatory and Start-up (RSU) team(s) and overall activities, where applicable.

RESPONSIBILITIES

  • Provide Regulatory and Start-Up expertise and / or technical consultancy on a variety of projects;
  • Determine expectations and parameters for operations and provides senior review and guidance for most documents prepared by colleagues
  • Oversee the execution of Country Regulatory & Start Up and / or Maintenance for assigned projects in accordance with the agreed RSU strategy
  • Review and analyze site performance metrics and processes to provide input in the development and implementation of process / system improvements, where applicable.
  • May be assigned to local / regional / global process improvement working groups.

  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
  • Where applicable, act as a Country Lead for projects with no regional / global Lead assigned.
  • Collaborate and communicate across departments to successfully deliver the agreed project scope in compliance with the agreed project plans and procedures.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report project and site performance metrics and out of scope activities as required.

  • Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
  • Perform pre-award activities including attendance at bid defense and sales meetings and support with material / presentations, review of proposals and oversight of the scope of work at country level.
  • May provide input into contract and budget template development.
  • Work with Quality Management to ensure appropriate quality standards for the duration of the project.
  • Identify and make recommendations to resolve ongoing training and development needs of staff, where applicable; prepare and deliver country-
  • specific training for less experienced staff and mentor and coach colleagues as required.

  • May deliver presentations / training to clients and professional bodies, as required.
  • May act as Local Regulatory and Contract Expert; may participate in feasibility and / or site identification activities.
  • May perform Site Selection Visits if trained as a monitor.
  • May undertake line management responsibilities, as required.
  • REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good negotiating and communication skills with ability to challenge
  • Good interpersonal skills, a strong team player
  • Good regulatory and / or technical writing skills
  • Thorough understanding of regulated clinical trial environment and knowledge of drug development process
  • Proven ability to exercise independent judgment taking calculated risks when making decisions
  • Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills
  • Good presentation skills
  • Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines
  • Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
  • Excellent understanding of study financial management
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Degree in life science-related discipline or professional equivalent.
  • At least 1 years’ relevant experience Regulatory and Start-Up experience (local submissions submitting local clinical studies) or equivalent combination of education, training and experience.
  • Fluent in English
  • Excellent interpersonal skills
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