Description As a QRST Specialist, you drive project work as a key contributor, aligning multiple stakeholders, and allocating regulatory resources when necessary. You help define the best approach to solving problems your team has not seen many times before. You work on cross-project or cross-functional teams, using your deep knowledge in the regulatory and compliance field to ensure that your delivery meets the highest standards. Responsibilities include:
- Provide guidance to teams in the area of design and analysis for complex projects. Create the regulatory framework for study design within regulatory requirements. Understand and identify potential risks and implications and mentor the team on trade-off decisions.
- Facilitate the identification of risk elements for specific projects to get early indication of areas of risks. Develop and identify contingency plans and work with project teams on the implementation. Anticipate regulatory responses through scenario planning and communicate areas of risk and advise on regulatory management and course of action on specific projects. Facilitate the risk management process and implement plans for assigned projects.
- Establish and track internal compliance management processes in collaboration with stakeholders, drives accountability with stakeholders/own teams for following the established processes, identifies sponsors and stakeholders and secures resources, ensures work alignment with compliance/privacy policies, identifies opportunities for and implements process improvements (e.g., automating the process), supports or promotes the adoption of processes.
- Conduct and analyze regulatory research to understand competitor activity and positioning and translate to regulatory strategy. Collaborate with counterparts to develop regulatory strategy, identify priorities and key issues in complex situations, and solve these problems with minimal guidance. Drive the preparation, planning, coordination, execution, review of quality standards and requirements, and ongoing maintenance of regulatory submission. Serve as the regulatory expert on cross-functional teams to ensure quality and compliance to requirements. Evaluate submission management processes, identifying and sharing best practices and efficiencies.
- Interpret existing regulations and guidance documents. Build an internal advocate network to drive outcomes (e.g., marketing, sales, clinical). Understand political processes and their impact on public policy and regulatory laws and regulations.
- Identify present and future unmet quality, regulatory, and compliance needs and generate Client approaches to address those needs. Create links to scalable processes, systems, procedures, or other solutions, with minimal guidance. Contribute domain expertise to regulatory, quality, clinical, product, design, and engineering teams.
- Plan, coordinate, prepare, and execute for meetings with regulatory agencies. Communicate with regulatory agencies to facilitate reviews.Minimum role qualification requires proficiency in:
- Registration and auditing
- Communication and influence
- Information governance
- Project scoping and execution
- Regulatory compliance
- Risk management
- Standards, regulations, and reporting
- Project/program management skills
- Domain specific knowledge and skills
- Technical, clinical, and partner knowledge
- Product excellence
- Business acumen
EEO: Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. |