ERGOMED

Senior Specialist/Manager, Regulatory Intelligence and Analytics

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Czech

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
  • Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
  • Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
  • Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
  • Ensure compliance with company procedures, processes, training records, systems and any other tools
  • Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
  • Provide training, coaching and mentoring to junior members of staff
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
  • Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.

Requirements

  • Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Strong previous experience within pharmaceutical or CRO industry or Regulatory body
  • Previous Project Management experience is desirable
  • Knowledge of Pharmacovigilance/Regulatory field
  • Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency.
  • Fluent Proficiency in English, both written and verbal.
  • Additional languages are desirable.
  • Strong organization skills and detailed orientated approach to work
Benefits
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Project ManagementRegulatory IntelligenceQuality ControlPharmacovigilanceICH GCPGVPRegulatory ComplianceDatabase ManagementRisk ManagementTraining and Mentoring
Soft Skills
LeadershipProblem SolvingCommunicationOrganizational SkillsDetail OrientationCoachingRelationship BuildingTeam CoordinationStrategic InputService Delivery