Global Process Owner - Clinical Trial Activities, Open to flexibility
Global Process Owner - Clinical Trial Activities, Open to flexibility
Drive excellence in process design and efficiency, creating value by integrating, standardising and sustaining assigned processes relevant to the conduct of pharmacovigilance (PV) across the global GSK PV enterprise (to include all Business units) in accordance with global legal/regulatory requirements and industry standards.
The position holder is a deep subject matter expert and responsible for developing, establishing and implementing a standard framework for assigned business processes by setting global strategy, defining system and process design, defining training strategies, performing project management and maintenance, monitoring and driving continuous improvement.
Key Responsibilities, what you will be doing:
You will design and develop a strategic and effective operating model for assigned PV processes to achieve efficiency and effectiveness across the global GSK PV enterprise.
Influence the external environment for assigned processes, representing GSK at PV meetings to include regulatory authorities, industry groups/think tanks and/or vendors to change the direction of PV and/or help shape the development of innovative methodologies.
You'll ensure that assigned processes are compliant with global legal/regulatory requirements and industry standards; actively monitor compliance with existing or newly initiated processes across products and regions; design and implement key performance indicators (KPI) to monitor performance of improved processes and measure results; collaborate with Safety Governance and Quality Leads to develop in-process controls and management monitoring strategies for assigned processes.
Prioritise, lead & enable process improvement initiatives, drive innovation in continuous improvement programs to deliver streamlined, efficient processes
You will build a strong network of stakeholders across GSK to support and influence cross functionally and across business units, to include stakeholders within Safety and Medical Governance, Vaccines and Consumer Health Safety as well as the broader business including those in Regulatory, Clinical, LOCs etc.
Deliver cohesive training and communication strategy for assigned processes globally; lead discussions, training and implementation for assigned processes with GSK offshore staff and outsourcing partners, as appropriate.
Benchmark standards: Solicit voice of the customer feedback, establish a performance baseline and measure the organisational performance; set global & holistic performance metrics to achieve an end-to-end process view of the organisation
You'll maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards pertaining to the assigned processes;
Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection and provide expert advice on responses to audit observations; be point of contact and interact with inspectors to support audits as appropriate.
Build network with other SMEs, stakeholders or single points of contacts (SPOC) internally (across GSK Pharma/ViiV), Vaccines and Consumer Health) and externally. Represent Safety in the different cross business process work streams or be the work stream lead when relevant.
Preference for role to be based at GSK Stockley Park, Uxbridge, UK, but can also be based at GSK Upper Providence, Collegeville, PA or GSK RTP, NC in US.
We look forward to receiving your application!
Closing date, Friday 16th November 2018.
- Bachelors Degree, General Science or Life Science Degree, Business process experience.
- In-depth experience in pharmaceutical industry, clinical safety or equivalent.
- Detailed understanding of pharmacovigilance regulations and methodologies with respect to Safety processes.
- Proven ability to work with stakeholders at all levels of the organization to establish a vision for change & influence to enable that change.
- Demonstrated experience in training on a wide range of core process improvements in both formal and informal settings to all levels of employees.
- Demonstrated track record of decision making and problem solution based on assessment of all relevant supporting and conflicting information/factors.
- Excellent leadership skills with the ability to work in a complex matrix environment, and influence at different levels of the organisation (GSK Pharma, Vaccines, Consumer Health), develop staff through coaching, training and support.
- Excellent verbal and written communication skills; able to present to groups to all levels of the organisation and externally to GSK
- Ability to lead change initiatives and communicate in a positive, transparent manner.
- Strong ability to think creatively, identify and implement improvements to processes and procedures
- Master's Degree in Pharmacovigilance.
GSK are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
GSK employ around 100,000 people in over 150 countries.
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