Director, Process Optimization Lead (Unified Regulatory Platform)

The Director, Process Optimization Lead (Unified Regulatory Platform) is responsible for driving an effective model for the development of end-to-end processes which connect across GRA capabilities for the establishment and advancement of the new URP platform. This role will focus on identifying opportunities for streamlining and standardizing regulatory processes, reducing cycle times, and improving overall efficiency. This role will take part in driving the definition and implementation of an end-to-end process management model across GRA capabilities, which is compatible and aligned with business data and technology solutions.

You will be responsible for:

• Develop and implement a global regulatory process strategy that aligns with overall business objectives.
• Take part in driving the definition and implementation of an end-to-end process management model, including connectivity with partner organizations for shared process ownership (e.g., Clinical, Safety, Supply Chain), and reach alignment with key stakeholders on implementation.
• Apply consistent process design methodologies/frameworks (e.g., six sigma, Lean, BPM) to identify opportunities for streamlining/standardizing regulatory processes, reducing cycle times, improving overall efficiency, and helping to align overlapping sub-processes across workflows.
• Take part in driving timely formation of URP project teams with appropriate leadership, skillsets, and resources (internal and external as required) to deliver future state end-to-end processes per capability. Escalate and resolve issues with resource availability to URP Leadership.
• Lead cross-functional teams to implement process development initiatives and monitor progress against goals and objectives, partnering with GRA Process Governance under the RODI organization to identify, prioritize and sequence initiatives.
• Collaborate with stakeholders to develop and implement process metrics and track progress against established benchmarks. Ensure engagement of all GRA functions and relevant partners in end-to-end process development activities and serve as a champion and spokesperson for the strategic importance of the work.
• Provide thought leadership on regulatory process development best practices and emerging trends.
• Contribute to the management and development of a team of process development experts to support the implementation of process initiatives.
• Partner within IT to ensure compatibility and alignment of the end-to-end process management model with the business data, the technology solutions, and the compliance framework.
• Advocate for and ensure appropriate change management to drive sustainability of the end-to-end process management model, and to ensure that regulatory staff are equipped with the necessary skills and knowledge to support optimized processes.

Qualifications / Requirements:

• Education:
• Minimum of a Bachelors degree in scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field.
• Advanced degree is preferred.
• Required:
• Minimum of 10 years experience in the pharmaceutical or healthcare industry.
• Mastery within regulatory affairs and advanced understanding of R&D process development.
• Strong analytical skills and the ability to translate data into information, and strategies into actionable plans.
• Experience leading strategic planning initiatives and managing complex projects.
• Experience working in a matrixed global organization.
• Excellent communication and collaboration skills.
• Demonstrated ability to lead cross-functional teams.
• Travel up to 10-25% of the time (domestic and international), defined by business needs.
• Preferred:
• Background in process optimization and change management.
• Experience with data visualization tools and business intelligence software.
• Green Belt / Black Belt

The anticipated base pay range for this position in the US is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits:

• Vacation up to 120 hours per calendar year
• Sick time up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
• Holiday pay, including Floating Holidays up to 13 days per calendar year
• Work, Personal and Family Time up to 40 hours per calendar year
• Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave 10 days
• Volunteer Leave 4 days
• Military Spouse Time-Off 80 hours

Additional information can be found through the link below.