Drive compliance standards and business implementation across key Medical Affairs activities in close collaboration with Global Governance, key functions, regions and countries. In conjunction with SME s, legal, compliance and Quality, assess compliance risks and operational gaps. Represent GMA Oncology on cross-functional and/or cross-divisional teams to continuously improve compliance standards and implement training for appropriate audience. Monitor effectiveness of internal controls and adherence to established standards.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
Drives the Medical Affairs compliance standards, based on applicable internal policies and regulations, for key operational activities and processes and drive global, regional and local implementation
In collaboration with Global Governance, SME s, legal, compliance, and Quality assesses compliance risks and gaps related to key Medical Affairs activities.
Optimize and protect Novartis' aspiration to deliver compliant and ethical scientific engagements (e.g. Congresses, Preceptorships, Scientific Standalones, etc.) which contribute to the enhancement of HCPs knowledge for the ultimate benefit and welfare of patients
Identify compliance risks across Medical Affairs and establish a sustainable mechanism to mitigate the risks and ensure compliance across organization. Drive compliance related projects for GMA
Provide proactive support with the assessment and management of operationally challenging business process and policy topics at the local, regional and global level
Help drive project management-related activities e.g. workshops, issue / risk log, etc. in relevant operational and business meetings to ensure key stakeholder alignment Proactively identify and propose pragmatic operational solutions to address compliance and/or business process issues / risks
Executes change management to promote a sustainable culture and mind set of compliance, across GMA, functions, Regions and countries, and embed it into daily work; identify opportunities to foster alignment and ownership of compliance at the regional and local level
In collaboration with key GMA functions, develop, implement, and deliver training to appropriate audience across the organization (Global, Regional and local) in order to ensure full compliance with key policies related to GMA ( NP4 Medical Affairs policy; SOPs)
Establish internal controls and metrics to measure effectiveness of processes, trainings and compliance standards
Contribute to cross-divisional projects or process improvement initiatives led by Global Governance, to align across divisions.
Support oversight for implementation of process improvement initiatives in close collaboration with Global Governance, key line functions, regions & countries, as appropriate
Support system improvement initiatives and provide business support and insight, based on user feedback. Support change management activities for successful implementation.
Contribute to or deputize for Oncology lead in established Global Governance Boards. Participate in Champion Forums and determine further action for Oncology, as appropriate
Participate in cross-functional GMA projects to improve compliance and drive optimization of compliance standards to gain sustainability in the business
Establish and maintain effective communication channels to optimize the interface between global, regional and local medical teams; raise awareness on compliance related matters
Work collaboratively with key stakeholders to establish appropriate mechanism (including processes, roles & responsibilities) to ensure readiness for Health Authority inspections and internal audits.
In conjunction with appropriate stakeholders, ensure strong remediation plan for any non-compliance findings
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor s Degree required, Advanced degree preferred
Excellent English language skills
6-8 years relevant experience in the pharmaceutical, healthcare, CRO, or academic institution, is highly preferred
Knowledge and or experience in leading medical affairs/compliance activities, including clinical trial operations, scientific communications and or Medical education, preferred.
Ability to proactively identify and propose streamlined solutions to address operational challenges
Demonstrated leadership for matrix teams in large organizations
Ability to facilitate and influence decision making and drive project teams for results
Ability to communicate effectively across different audience and organizational level
External focus to ensure full awareness of trends and proactively address needs based on external demands
Facilitation skills for bridging between scientific and business, and for managing effective international and cross-divisional collaboration
Proven self-starter with experience in building capabilities based on defined business needs across geography and functions
Able to influence decision making and drive project teams for superior results
Proven ability to build strong, effective relationships with internal partners at all levels of the organization
Change management skills to sustain a cultural of high ethical standards and compliance
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