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Mgr, Regulatory Intelligence
hace 2 semanas
**Description**
**JOB SUMMARY**:
The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations.
**JOB RESPONSIBILITIES**:
- Ensures that clinical regulatory intelligence is collected and maintained in Syneos Health Regulatory Intelligence System (RIS):
- Ensures that the country specific regulatory requirements are current and accurate and available for services offered by Syneos Health for countries in which the organization operates or intends to operate in.
- Ensures that regulatory intelligence data is available in a standardized format within the Regulatory Intelligence System so that it can be used for project work, client consultation etc.
- Interacts with external and internal experts to collect country and region-specific regulatory intelligence.
- Work closely with Country SMEs contributing to the overall understanding of the local regulatory landscape.
- Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
- Understands applicable local, national, and regional regulations and translates them into organizational best practices.
- Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs.
- Reviews surveillance alerts and queries and determine actions to be taken through to implementation.
- Advises, consults, and makes final recommendations to all aspects of clinical regulatory intelligence.
- Makes recommendations in expertise to internal stakeholders.
- Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.
- Supports impact assessments of regulatory documents and guidelines on Syneos Health procedures as applicable and as assigned by management.
- Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.
- Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System
- Provides regulatory and technical training within the department and/or other departments/stakeholders, as required.
- May include line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations.
- Timely and active participation and completion of all company and departmental requirements such as time reporting, meetings, performance reviews, etc.
- Other tasks as required
**Qualifications**
**QUALIFICATION REQUIREMENTS**
- BS degree or equivalent demonstrated experience in a relevant field
- Clinical research experience required including significant regulatory intelligence experience or regulatory affairs or regulatory operations, preferably from a clinical research organization.
- Good knowledge of country specific and regional regulations.
- Ability to analyze information across multiple sources and manage substantial amounts of details.
- Strong research skills required to support routine surveillance activities to detect, monitor, and synthesize complex regulatory information.
- Ability to react to internal and external changes, trends and development in the regulatory environment that may impact Syneos Health
- Knowledge of niche regulatory topics preferred.
- Excellent interpersonal and communication skills.
- Fluency in speaking, writing, and reading English.
- Exercises judgment within defined procedures and practices to determine proper action.
- Excellent customer service skills, with the ability to work both within teams and independently.
- Good people management, project management, problem-solving, and decision-making skills.
- Good initiative, adaptability, and pro-activity.
**Disclaimer**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained here should be construed to create an employment contract. Occasionally, needed skills/experiences for jobs are expressed in brief terms. Any language held here is intended to fully follow all obligations imposed by the legislation of each country in which it works, including the implementation of the EU Equality Directive, in relation to the recruitmen
