Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
Executive Profile

Experienced operational professional in the planning and management of regulatory submissions to worldwide agencies using state-of-the-art practices. My ability to understand concepts and question seeming inefficiencies has allowed for continual process improvements in the Regulatory Operations arena.

Skill Highlights

Strong motivational skills

Analytical skills / metric focused

Process centric with strong project management skills

Six Sigma

Core Accomplishments

I led a team that designed and installed a new organization, Global Dossier Management. This was in response to the redundancies of roles and inefficiencies as a result of the merger of the Regulatory Coordination and Regulatory Operations departments. This was a multi-year, multi-phased project in which roles were eliminated, merged and redefined to focus on active management of activity rather than passive tracking. By combining roles and focusing on core submission management activity, a savings of 11 (22%) FTEs was realized.

Aligned the team to support the increased activity as a result of the Schering Plough merger, a~50% increase product workload associated with merger with only a 16% staff increase.Expanded the role to the European office to build regional expertise to support the company’s most complex regulatory environment.

Ongoing reevaluation of the organization, making changes to support the changing environment. For example the need to support emerging market objectives.

I managed the Submission Manufacturing project to reduce global submission release cycle time. This was a 3 phase project that focused on both process and enabling technology. The single date approach was eliminated and replaced with data-driven requirements based on size and complexity. This project also included the implementation of an enabling technology to facilitate detailed, proactive submission management and replace multiple tracking methods.

Reduced Global Release Cycle time from 150 days to 90 days

10-14 days of waste (touch time) eliminated per filing for small submissions and 5-8 days of waste eliminated per filing for medium/large submissions

Partnered with Octagon Research to develop and deliver a new technology that supports dynamic, multi-regional planning and delivery.

Project won Merck-wide Sigma innovation award

I assumed the leadership of two work streams for the Global Product Registration Management Team when the sponsors identified that the time lines were in jeopardy. The documentation workstream included the creation of multiple SOPs, User Guides and Training Materials. I quickly analyzed the problems facing the team and facilitated a significant change in scope to ensure usable training and materials would be produced on time. The UAT workstream was an end-of-year MRL objective that required managing both internal and contract resources. I successfully led the team to completion of the UAT to meet the objective,

Developed e-learning for company-wide users that allowed us to decrease the amount of hands-on training.

When it was identified that regional trainers could not be installed on time, worked to develop GRO resources to fill the gap. This team of 8 trained more than 600 worldwide users prior to go live.

Implemented a new UAT schedule and daily objective calls to accelerate test script execution.

Professional Experience
06/2003 to Current Director -Worldwide Regulatory Operations Merck & Co. | City, STATE,

Provide overall management support and oversee the completion of all marketing application submissions for Merck. Manged personnel and associated resources in a manner that is in alignment with submission production and release activities.

Developed strategies to execute timely release of high-quality submissions The overall result was a 97% on-time release of all planned and ad hoc activities, while maintaining Merck’s high standard for quality and accuracy.

Participated in and led numerous process improvement initiatives to reduce cycle-time and optimize efficiency in support of the overall portfolio of activities. Awarded two MRL, and one Merck Sigma award for process innovations.

Developed a staff of 5 individuals into a high-performing team over three distinct functional areas. Oversaw and participated in all aspects of employee developing including hiring, mentoring, training development and creation of job families and roles to ensure adequate growth potential.

10/1996 to 06/2003 Manager - Regulatory Submissions Processes and Standards Merck And Co. | City, STATE,

Participated in the design, implementation, and attention of new business processes covering all elements of process design and reengineering, from the conceptual through realization, overcoming resistance to change.

Served as process owner for the Worldwide Marketing Application process, requiring skillful negotiations with Clinical, Nonclinical, and Project Management. Released WMA GDP, a company-wide document that ensured overall alignment of the process from end-to-end.

Chaired the Process Review and Improvement Team (PRIT) to improve operational efficiencies. Oversaw the successful completion of more than 25 initiatives resulting in decreases in cycle time of more than 12 weeks overall and the combined FTE savings of 9 employees.

Developed departments first mentoring program to expand leadership skills of less-experienced employees. More than 80% of employees who participated were identified by their management as having significantly improved leadership skills.

08/1988 to 10/1996 Research Biologist - Immunology and Inflammation Merck And Co. | City, STATE,

Responsible for establishing, characterizing and conducting in vivo and in vitro models to support the objectives of the Immunology and Inflammation Department.

04/1985 to 04/1988 Lieutenant JG United States Department Of The Navy | City, STATE,

Logistical responsibilities for special operations supporting Atlantic fleet forces. .

Supervised 33 men directly, oversaw 185 man operation.

Raised company performance scores by 60% in 18 months

Expected in 2013 MPH | Public Health - Epidemiology Johns Hopkins University, Baltimore, MD GPA:
Expected in 2009 Black Belt | Six Sigma Villanova University, Viillanova, PA GPA:
Expected in 1996 MBA | International Project Management Montclair University, Montclair, NJ GPA:
Expected in 1985 Bachelor of Science | Biochemistry Long Island University, Southampton, NY GPA:

Minor in mathematics

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School Attended

  • Johns Hopkins University
  • Villanova University
  • Montclair University
  • Long Island University

Job Titles Held:

  • Director -Worldwide Regulatory Operations
  • Manager - Regulatory Submissions Processes and Standards
  • Research Biologist - Immunology and Inflammation
  • Lieutenant JG


  • MPH
  • Black Belt
  • MBA
  • Bachelor of Science

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