Core Job Responsibilities:
- Provide medical governance. The RSA Director will serve as the primary contact for medical governance requirements within the affiliate. This will include accountability for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
- Provide leadership and direction to clinical research, regulatory affairs and medical services staff. The RSA Director must ensure appropriate staffing, training and development in order to meet business needs and deliver quality services. He/she must develop appropriate succession planning to ensure ongoing development of key skill sets in order to minimize disruption to the company’s business. Ensures that all members of the group are motivated to contribute fully to the realization of the company’s mission, vision, goals, and objectives. Encourages employees to identify innovative approaches to enhance organizational performance. Fosters the development of management practices, which focuses on a cohesive working environment and continuous improvement in the relationships with internal and external stakeholders.
- Pharmacovigilance: The incumbent will ensure that an effective Pharmacovigilance system operates within the affiliate, and that reporting requirements to competent authorities for adverse events and other safety related documents are adhered to. The RSA Director should proactively anticipate possible safety signals and communicate appropriately according to standard procedures
- Leverage the organization’s strength in clinical research activities within the global company. The incumbent must manage all local clinical study activities within defined standards and budgets. He/she must ensure compliance with corporate Standard Operating Procedures SOP’s, GCP, and local regulatory requirements pertaining to the conduct of clinical studies.
- Lead clinical support activities. The incumbent is primarily responsible for the design and implementation of all local clinical trials and feasibility studies as well as responds quickly and effectively to adverse events by ensuring strong capability in drug safety and Pharmacovigilance areas. He/she will be responsible for the design and execution of phase IV, and PMOS studies,
- Promotional material review & approval process: to provide final sign-off for label changes to ensure that all requested changes are in line with approved product label. To act as final signatory on all other relevant document such as label changes.
- Provide medical support to the marketing and product planning groups for new products, line extensions, and new indications.
- Support public affairs and reimbursement activities within the affiliate.
Position Accountability / Scope:
- Management Skills
- Uses resources effectively and efficiently.
- Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.
- Maintain and operate within budget.
- Capable of analyzing and investigating issues and problem solving.
- Communication Skills
- Effectively practices listening skills before responding to issues.
- Effectively writes, presents and communicates information to internal and external clients, including divisional management.
- Effective negotiation skills.
- Total Quality Management (TQM) Skills
- Demonstrates the ability to exercise good judgment on regulatory and compliance issues.
- Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.
- Able to insure compliance to regulations from direct reports and outside contractors (CRO).
- Problem/Conflict Solving Ability
- Ability to analyze situations and conflicts without pre-judgments and assumptions
- Listens carefully and with an open mind
- Provides direct, complete, corrective and actionable feedback
- Reads situations quickly
- Settles disputes
- Negotiates common ground for win/win solutions
- Priority Setting
- Prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization.
- Quickly senses what will help or hinder accomplishing a goal
- Ability to handle several responsibilities simultaneously
- Respect to deadlines dates and projects’ deadlines
- Strong work ethics and emphasis on quality of work performed
- Staff Development
- Provides challenging, intellectually stimulating and ambitious tasks
- Holds frequent development discussions
- Recognizes team and staff members individual strengths and weaknesses
- Motivates team members and direct reports
Minimum Experience/Knowledge required:
- Above bachelor’s degree in Pharmacy or relevant major
- 15~18 yrs of experience or more