Compliance & Analytics Consultant

Provide site perspectives to the QST Leads and Global Head of 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.

- Plans, designs, and participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of Regulatory Labeling Submissions at the relevant sites. May serve as a subject matter expert (or SME In-training) for lines on metrics, knowledge sharing, technology, or specific work processes, providing advice and guidance to other QST colleagues, as appropriate. Provide ongoing analysis of data resulting from the quality review of regulatory labeling submission documents produced within the department. Assesses timeliness of Safety Variation submissions processed in accordance with relevant guidelines and internal standards.
- 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 expertise of Regulatory Labeling Submissions due to Safety Variations and analysis, to develop/enhance the identification and investigation of causal candidates precipitating from root cause.
- 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.
- Participates in and contributes fully to project teams, task forces and or committees taking responsibility for timelines and deliverables for relevant business processes.
- Makes decisions, as appropriate, regarding review of tracking and submission processes that may affect projects, processes, product delivery and expenditure on existing or alternative resources.
- 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 Core data sheet and Local Product Documents requiring updates due to Safety Variations (S1, S2) and scheduled and/or submitted according to internal and regulatory timelines.
- Generation and quality control check of integrated compliance data relative to areas of delay (with safety variation submission), trending of aggregate data, root cause analysis and corrective and preventative action planning.
- Ensure linkages with Global Labeling Leads, Labeling Managers, Country Offices, and Medical Documentation Labeling, and Submission Management in proactively managing compliance and corrective action planning in support of continuous improvement across Safety Variation submission/tracking processes. Management and oversight of processes for analytics and reporting of integrated compliance and performance information across processes and delayed/late Safety Variation submissions.
- Contributes to development and implementation of strategies for compliance/performance and process analytics, information delivery and corrective action implementation.
- Provides input on quality services and policies working with QST-CA Directors/Sr. Director. Actively participates in strategy decisions related to global quality technology. Focus quality services by working with other functional lines and sites, better ensuring deliverables for the processes and products are met, along with safety needs.
- 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.

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 Global and Local Labelling documents. Excel skills must be strong.

- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission 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 Qualifications (ie, preferred education, experience, attributes)
- 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.