Assoc. Director, Regulatory Affairs - Process Change Management Delivery Lead Job

Gwynedd, PA, US
August 24 2017
Organization Type
Assoc. Director, Regulatory Affairs - Process Change Management Delivery Lead-REG003126


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive bio-pharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Global Regulatory and Clinical Safety (GRACS) Process Change Management Delivery (PCMD) Lead is part of the Business Process Management (BPM) team in Merck’s GRACS organization. The PCMD Lead will be responsible for the design and implementation of end-to-end change management efforts for high-complexity projects in the GRACS Change Initiatives Portfolio. Initially, there will be an intensive focus on support for the Information Management Strategy program and the set of supporting projects. Activities and deliverables will focus on project-based change management as it relates to business readiness, executive alignment/commitment, sponsorship, communications, organization/role alignment, training, documentation, and performance support for planned and active projects within the portfolio. The PCMD Lead must be able to work effectively with project stakeholders, leaders and team members throughout the GRACS organization and beyond as needed for process changes. This role will leverage the GRACS Change COE approach for a project-based best practice platform for continual process improvement initiatives and collaborate with the GRACS Change Center of Excellence (COE) Lead.

The Lead will also act as a coach and advisor on less complex projects led by business process leads and project managers by providing guidance and instruction on change management tools, methodology and best practices for managing change initiatives in the GRACS Change Initiative Portfolio, aligned with the GRACS Change COE maintained toolset & chosen methodology. The candidate must possess exceptional communication and relationship building skills at all levels of the organization. This role reports to the BPM Lead and will work closely with the GRACS Change Management Center of Excellence lead to facilitate alignment of activities with the GRACS Change Management Center of Excellence.


- Work with GRACS Change Management COE lead, business leads, process owners, portfolio leads, and project managers to assess both the organization's readiness for change and the change impact of a proposed programs in the GRACS Change Initiative Portfolio to determine appropriate application of Change Management strategies, tools, and techniques for use for strategic and tactical Change Management support.

- Lead, develop, and implement integrated fit for purpose Change Management strategies and plans to drive adoption for high-complexity cross-functional change projects and programs.

- Within the context of assigned projects, support leaders in understanding and tracking the overall changes impacting their departments and functions, and proactively partner to build and implement readiness plans.

- Work with project managers and key stakeholders to plan and perform change readiness milestone check-ins.

- Provide guidance on change management best practices to change initiative project teams.

- Coordinate and deliver training and provide education on change management to change initiative project teams.

- Act as a coach and advisor to business change champions by performing milestone check-ins, providing resources and guidance on CM best practices for projects within the GRACS Change Initiative Portfolio.

- Contribute to developing and maintaining the existing change management on-boarding materials for flexible staffing model in the Business Process & Information Management organization where sourced PM, BA, and CM leads are brought on to augment existing staff.

- Coach change initiative project teams on how to integrate and apply the GRACS Change Management toolkit to a project.

- Contribute to the maintenance of a CM Framework & Toolkit for the Change Initiative Portfolio and larger GRACS Change Management Community.

- Contribute to the GRACS Change Management COE Toolkit & Resource Library for change initiatives in alignment with the GRACS PM Toolkit and Resource Library.


Education Requirement:

- Bachelor’s Degree required with emphasis in business/communications and/or human resources.

Required Experience

- Minimum of 5 years relevant experience in the pharmaceutical industry, including direct experience in the implementation of large-scale business change initiatives in Regulatory and/or Safety.

- Good working knowledge and experience in the Change Management challenges surrounding the implementation of new systems and processes in a multi-stakeholder, multi-organization environment.

- Solid understanding of change management, communication, organizational effectiveness, training and instructional design concepts and best practices.

- Detailed understanding of the impact of change, interdependencies, and impact on business.

- Possess advanced leadership skills, business acumen and ability to effectively execute against change management strategies and plans.

- Strong planning skills.

- Exceptional oral and written communications skills.

- Exceptional client relationship-building skills.

- Strong coaching skills and ability to do so at all levels of the organization.

- Advanced ability with standard Microsoft Office applications (Excel, Word, PowerPoint, SharePoint and Outlook).

Preferred Experience:

- Proficiency in Visio, Change Initiatives (e.g., Sigma), Change Management Certification, PMI and/or PMP Certification.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Regulatory Affairs Generic

Job Title:Assoc. Dir, Regulatory Affairs

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: No

Number of Openings: 1

Company Trade Name:Merck