Regulatory Health Project Manager Occupation-specific Competencies (GS 11/12/13)

Transcription

1 Core Competencies 1. Communication Accountability and Transparency Internal Awareness External Awareness Conflict Leveraging Diversity Fostering Collaboration Partner/ Customer Service Orientation CTP Regulatory Knowledge... 4 (GS 11/12/13) 1. Scientific Knowledge Regulatory Review Effective Planning and Implementation in Project Leading People in Project Driving Results in Project

2 CTP Core Competencies 1. Communication A. Communicating Effectively across CTP B. Communicating Effectively with Colleagues and Stakeholders C. Demonstrating effective Interpersonal/ Relationship Skills 2. Accountability and Transparency A. Holding Self Accountable for Program Responsibilities B. Demonstrating High Standards of Ethics and Integrity Is professional and courteous in all written and oral communication. Expresses self in a clear, concise, and organized manner in written and oral communication. Tailors communication based on the styles and needs of others. Keeps others well informed on pertinent CTP-related issues. Actively listens and asks appropriate questions to ensure that understanding of the situation is obtained before formulating a response. Escalates issues that warrant immediate attention in an effective and timely manner. Acts in an ethical and honest manner that is consistent with organizational values in all situations. Performs job duties effectively within required timeframes. Takes responsibility for own actions. Admits personal mistakes, learns from them, and takes action to correct the situation. Uses discretion when handling sensitive matters/content. 2

3 CTP Core Competencies 3. Internal Awareness 4. External Awareness 5. Conflict A. Knowledge of CTP and Your Office A. Knowledge of Current Events in Tobacco Community/Stakeholders A. Recognizing Conflicting Interests B. Addressing Conflict in Appropriate Manner Demonstrates an understanding of the organization s functions and responsibilities. Considers organization s mission, vision, values and strategic goals and objectives in work efforts. Maintains knowledge of capabilities, capacities and constraints of the organization. Keeps abreast of changes in the external environment and understands the potential impact on the organization and job duties. Keeps informed of what FDA, HHS, and other agencies of the Federal Government are doing related to tobacco control and regulation. Keeps informed of FDA, HHS, and Federal government regulations, policies and procedures that could affect job duties. Recognizes that others hold differing opinions. Works to resolve conflicts in a constructive and tactful manner. Informs supervisor when conflicts between colleagues get in the way of job duties. 3

4 CTP Core Competencies 6. Leveraging Diversity 7. Fostering Collaboration 8. Partner/ Customer Service Orientation 9. CTP Regulatory Knowledge A. Valuing a Blend of Skills and Perspectives A. Developing CTP-Wide Working Relationships B. Working on Multi- Disciplinary Teams C. Sharing Knowledge with Colleagues A. Ensuring a High Degree of Responsiveness to Organizational Leadership, Customers, and Stakeholders A. Applying Knowledge of FDA and CTP Laws, Regulations, and Policies Values working with people from different backgrounds and views and seeks out diverse opinions and viewpoints. Encourages colleagues to utilize their diverse skill sets and viewpoints. Works well with others towards achieving a common goal. Establishes rapport and trust with team members and others throughout CTP, FDA, and HHS. Shares knowledge with others through both formal and informal avenues. Helps to remove barriers that get in the way of effective teamwork. Treats all partners/customers (internal and external) in a courteous and professional manner. Provides timely and responsive service (e.g., , phone calls, etc.) to all partners/customers. Is open to feedback from partners/customers. Demonstrates knowledge of the Family Smoking Prevention and Tobacco Control Act and applicable sections of the Federal Food, Drug and Cosmetic Act, regulations and guidance documents. Maintains knowledge of FDA regulations, legislation, and administrative procedures applicable to job duties. 4

5 1. Scientific Knowledge A. Demonstrates knowledge of principles, theories, and practices related to scientific fields within health sciences B. Applies scientific knowledge to regulatory review and related projects Demonstrates a professional understanding of the principles and limitations of the health sciences (e.g., biology, physical sciences) and scientific theories, concepts, and methodology. Applies scientific knowledge when carrying out projects involving the research and review of tobacco product. Analyzes a wide variety of situations, identifies problems, and suggests courses of action for scientific specialists to pursue. 5

6 2. Regulatory Review A. Applies knowledge of laws, regulations, and policies for the oversight of the FDA regulatory review process Serves as a regulatory advisor on project teams; consistently demonstrates a comprehensive, up-to-date knowledge of regulatory processes and law (e.g., Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act) to process and evaluate regulatory submissions. Interprets regulatory law to effectively evaluate options for implementing the Tobacco Control Act. Demonstrates a comprehensive knowledge of regulatory databases to document and track information; ensures databases are kept up-to-date, and recommends business requirements for system enhancements. Assists in establishing standard operating procedures (SOP) and related job aids to adhere to office-approved business practices for managing regulatory submissions, reviews, and other projects. Develops and uses templates and comprehensive knowledge of regulatory science and law to prepare written documents (e.g. reviews, letters, minutes). Demonstrates the ability to manage/ monitor status of multiple, complex concurrent projects including strategic planning, establishing timelines, setting milestones, evaluating progress, identify obstacles and recommends solutions. Effectively uses technology and resources (e.g., scientific databases). 6

7 3. Effective Planning and Implementation in Project A. Develops strategic plans and objectives B. Develops and manages project plans Assists with development of project planning in complex projects or develops project plans for new substantial projects. Researches and collaborate to ensure clear understanding of project or particular function of a project. Identifies stakeholders and recommends solutions to account for stakeholders in project planning. Translates the strategic plan into effective organizational objectives with minimal oversight. Plans and manages projects effectively. Effectively allocates resources towards meeting strategic and tactical goals. 7

8 4. Leading People in Project A. Empowers others B. Provides direction and guidance C. Attracts, develops, manages, and retains a high performance team D. Manages difficult conversations E. Manages crossorganizational teams F. Leads without formal authority Assists in delegating appropriately challenging assignments. Ensures that team members understand their roles and expectations of the project. Utilizes and leverages employees abilities appropriately. Recommends and ensures high quality, diverse project teams. Acts as a coach by providing guidance and constructive feedback. Ensures that employees have the resources necessary to maintain a high performance. Assists in resolving difficult conversations with employees. Manages cross functional teams within CTP. 8

9 5. Driving Results in Project A. Meets organizational goals and customer expectations B. Makes well-informed, effective, and timely decisions C. Ensures accountability Makes timely decisions that produce high-quality results by applying comprehensive technical knowledge and addressing risks/benefits. Develops performance metrics to monitor results. Identifies and analyzes unusual problems and issues and recommends solutions. Holds self and others accountable for timely results. Assumes stewardship role to the Center. 9