What are the responsibilities and job description for the Regulatory and Medical Affairs - Medical Policy Advisor (Medical Research) position at Omni Inclusive?
Position Summary
The Medical Policy Advisor is a trusted and agile matrix partner who provides guidance on medical activities anchored on quality and compliance, ethics and integrity for the benefit of our patients. The Medical Policy Advisor is a member of the Medical Policy team within the Global Medical Excellence organization. This team plays a critical role to advance best practices in global medical activities through policy and governance, guidance and risk assessment, and monitoring.
Key Responsibilities
Provides subject matter expertise regarding medical research including scientific collaborations and partnerships aligned to related external guidelines and requirements.
Evaluates processes and / or procedural documents for improvement and implementation of practical solutions.
Interprets procedural documents, processes, and documentation requirements as well as external regulations and standards to provide consultation and advice to stakeholders while ensuring matrix alignment and consistency.
Partners in the development and implementation of appropriate processes, process improvements, and procedural documents in alignment with Client policies and external guidelines.
Writes and / or contributes to the review and revisions of policies and procedures.
Qualifications & Experience
College degree with a minimum of 3 years-experience in the pharmaceutical or related industry (e.g., healthcare, research)
Demonstrated experience in post-marketing medical affairs GxP activities (e.g., research, medical education) and related regulations, standards, and business requirements
Familiarity with healthcare compliance and financial reporting (e.g., Sunshine Act)
Experience in writing procedural documents and leading process improvements
Excellent organizational, written and oral communication, facilitation, interpersonal and leadership skills
Ability to facilitate discussions and decision-making with cross-functional and cross-cultural team members; ability to influence without authority and negotiate appropriate solutions and proven ability to establish strong internal and external stakeholder relationships
Ability to clearly communicate policies and rationale to diverse audience and to present training to cross-functional global colleagues
Track record of success in leading complex projects and problem solving. Demonstrated strong project management, analytical, and critical thinking skills
Change management and process improvement experience highly desired
Experience working with third-party vendors
Physical presence at the Client worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
The top skills are :
Demonstrated experience in post-marketing medical affairs GxP activities (e.g., research, medical education) and related regulations, standards, and business requirements
Familiarity with healthcare compliance and financial reporting (e.g., Sunshine Act)
Experience writing procedural documents and leading process improvements
Ability to clearly communicate policies and rationale to diverse audience and to present training to cross-functional global colleagues
Track record of success in leading complex projects and problem solving. Demonstrated strong project management, analytical, and critical thinking skills
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