Demonstrates proven success in roles and thorough abilities in one or more of the following areas:
- Minimum of 18+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
- Preferable IT background to understand larger impact of business, organization mission and strategies, architecture / technical complexities on the program
- Experienced in leading strategic and tactical discussions with Senior stakeholders
- MBA, MS or any other advanced degree is preferred
- Lead Pre-Sales and Sales activities including Proposal Development, Solution and Value Proposition; in collaboration with larger Infosys teams, lead proposal development process; solution formulation; proposal pricing; client presentation; contract negotiations and deal closure
- Engage and maintain contacts with key client stakeholders; proactively identify opportunities for business development, and lead workstreams to aid development of new business opportunities
- Provide leadership in critical engagements and drive successful outcomes, and have ability to pursue and grow deep client relationships
- Be a subject matter expert in areas such as Risk Management, Quality Management, Document Management, and Compliance Management
- Understands how key risks and controls have an impact on the business from a pharma, business, operational and/or system perspective
- Demonstrate a clear understanding of the risks and opportunities related to standard operating procedures and the governance policy framework
- Makes recommendations for risk mitigation and audit strategies based on accurate identification of potential market, business, pharmaceutical, operational, IT and talent risks
- Experienced with planning and conducting functional and domain specific risk assessment of Pharma and Medical Device programs / projects
- Experienced in using industry wide risk management tools, and to perform root cause analysis on trends and address deviations via preventive, detective and corrective measures
- Experience of working with Risk Management, Security and Compliance Policy frameworks, ISEC & Compliance, Records Management
- Applies an understanding of company short-term and long-term strategic objectives and the risks that apply
- Is knowledgeable about market and regulatory frameworks and trends that have the potential for substantive impact on organization strategies, policies, or risks
- Knowledge and hands on experience conducting periodic or control assessment, audits and risk assessments
- Knowledge of various validation tools and templates used throughout the Pharma and Medical Device industry
- Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals
- Participate in practice development activities; coach consultants; participate in consultant training and staffing processes
- AI Risk Assurance
- Successful track record using industry leading tools and techniques to conduct risk assessments and compliance checks to build digital solutions in a multi-disciplinary, multi-vendor corporate setting, and to validate assets
- Experienced in leading strategic and tactical discussions with CxO level
- Industry experiences working directly at pharmaceutical, medical devices or pharma distributor organization is a plus
