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Compliance & Analytics Consultant

Eingestellt von Synectics

Gesuchte Skills: Support, Consultant

Projektbeschreibung

Provide site perspectives to department Leads and Global Head of Quality Standards & Training (QST). Combined with adherence to safety, regulatory, and project timelines, bridges partnership with customers to support in line quality ownership and participates in the development of efficient tools and techniques to support customers. Provides input on quality services and policies working with QST Directors/Sr. Director. Actively participates in strategy decisions related to global quality technology.

- Plans, designs, and participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information at the relevant site(s). May serve as a subject matter expert (or SME In-training) for Safety Evaluation & Reporting (SER), lines on metrics, knowledge sharing, technology, or specific work processes, providing advice and guidance to other colleagues, as appropriate Makes decisions, as appropriate, regarding review of safety processes that may affect projects, processes, product delivery and expenditure on existing or alternative resources.
- Performs reviews of submission data and business processes/procedures to support continuous process improvement and organizational evolution, driving timely measurable and actionable feedback for proactive change. Performs quality review of compliance data.
- Manages the completion of complex tasks by applying technical skills, including but not limited to Excel and specialized knowledge to coordinate findings, conduct root cause analysis, and corrective action planning. Utilizes technology, including but not limited to, Excel to increase efficiency and better ensure quality outputs. Leverages Excel for collection and compilation of compliance data.
- Utilizes expertise of AE reporting and analysis, to develop/enhance the identification and investigation of causal candidates precipitating from root cause.
- Participates in and contributes fully to project teams, task forces and or committees taking responsibility for timelines and deliverables for relevant business processes.
- Collaborates effectively with the Business Units and Partner Lines. Participates in Virtual Teams as applicable.
- Compilation of integrated compliance and performance metrics across processes for adverse event reports forwarded to the appropriate department for processing.
- Generation and quality control check of integrated compliance data relative to areas of delay (with case processing), trending of aggregate data, root cause analysis and corrective and preventative action planning.
- Ensure linkages with Supplying Country Organizations, US Supplying Organizations, in proactively managing compliance and corrective action planning in support of continuous improvement across AE reporting processes. Management and oversight of processes for analytics and reporting of integrated compliance and performance information across adverse event reporting processes and late reports.
- Contributes to development and implementation of strategies for compliance/performance and process analytics, information delivery and corrective action implementation.
- May lead small operational teams within and across disciplines. Participates in the development of people, working with the QST Leadership to provide support to other colleagues across all sites. May mentor/coach new staff as required. Travels to other QST sites as required.
- May provide support during regulatory inspections and internal audits.
- Provide linkages between SER therapeutic teams and functional areas and internal and external customers relative to compliance support activities.
- May provide ongoing analysis of data resulting from the quality review of regulatory submission documents/cases/aggregate reports produced.
- Assesses timeliness of adverse event reports processed by SER in accordance with relevant guidelines and internal standards.

SKILLS:

Team is really looking for this candidate to have solid working experience in Excel as well as working knowledge and experience in the review and/or submission of Individual Case Safety Reports and safety metrics focusing on Metrics and Regulatory Submission Documents. Excel skills must be strong.

- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission electronic reporting requirements, and other relevant regulations and guidance.
- Technical Skill Requirements: Strategic Thinking, Technical Expertise, Scientific/Administrative Excellence, Organizational Development, Project and Process Management & meeting established deadlines, Presentation/Influencing/Organizational Skills, Multi-tasking, Team and Matrix Structure, Analytical and Statistical Skills, and Systems Technologies
- Bachelor's degree in a science or business related discipline is required. Advanced degree desired
- Training and/or demonstrated experience in relevant technical and behavioral competencies
- Clinical development and/or post-marketing and regulatory expertise
- Strong verbal, written, communication and presentation skills
- Innovative and strategic thinking ability
- Strong computer skills desired
- Strong commitment to quality and data integrity.

Projektdetails

  • Einsatzort:

    Bridgewater, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Synectics