Associate Manager, Compliance - III*

Pay rate: $82 - $90.50

The Associate Director, Evidence Generation Compliance is responsible for ensuring that all evidence generating activities (e.g., observational research, clinical outcomes studies, RWE initiatives, investigator sponsored research, and collaborative research programs) are executed in accordance with internal policies, regulatory requirements, and industry best practices. This role Products audit readiness, strengthens governance, and drives consistency and rigor in processes and documentation across the Evidence Generation function.
The ideal candidate is a detail oriented compliance leader experienced in medical affairs operations, governance, and documentation management, with the ability to collaborate across cross functional teams and influence best practices globally.
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Key Responsibilities
Audit Readiness & Documentation Excellence
Ensure all Evidence Generation documentation is consistently audit ready, complete, current, and compliant with internal standards and external regulatory expectations.
Conduct periodic quality checks and systems-of-record reviews across programs and studies to proactively identify gaps and areas for improvement.
Partner with functional leads and study owners to support robust, accurate, and timely documentation practices.

SOP Reinforcement, Maintenance, and Training
Reinforce adherence to Standard Operating Procedures (SOPs), Work Instructions, and controlled documents across Evidence Generation and Medical Affairs.
Lead the update, revision, and creation of SOPs as needed, ensuring alignment with evolving regulatory guidelines and industry best practices.
Develop and deliver targeted training programs to strengthen compliance awareness and procedural consistency across teams.
Governance & Process Oversight
Manage and continuously improve Evidence Generation governance documentation, ensuring version control, accessibility, and alignment with organizational quality frameworks.
Support governance body operations (e.g., review committees, oversight boards) by preparing materials, maintaining records, and ensuring compliant decision making processes.
Ensure all proposals, concepts, and new study requests are reviewed by the appropriate governance body in a timely and compliant manner, including triage of submissions, coordination of review schedules, and communication of outcomes to stakeholders.
Implement and monitor compliance KPIs, metrics, and dashboards to ensure ongoing transparency and operational excellence.

Cross-Functional Collaboration
Partner with Legal, Compliance, Regulatory, and Quality Assurance to ensure holistic alignment and timely issue resolution.
Provide compliance guidance during planning and execution of evidence generation activities, including protocol development, contracting, data sharing, authorship, and publication processes.

Continuous Improvement
Identify opportunities to streamline workflows, reduce procedural burden, and enhance operational efficiency while maintaining compliance rigor.
Support change management efforts, including communication planning and stakeholder alignment, for new or updated processes.