R&D Compliance Manager (t559)

  • Contract Duration: 12+ months
  • Research & Development
  • Cambridge, MA

Website Lenox Executive Search

Lenox Executive Search is seeking a highly motivated R&D Compliance Sr. Manager to fill a 12-month contractual role with a leading global pharmaceutical company based in Cambridge, MA.  This role involves Global Regulatory Affairs functions within R&D and includes QMS GRA Compliance, Change Management and Global Reporting Communications.

MUST HAVES:
– Strong Soft Skills: self-motivated, critical thinker, proactive, work independently and well as collaboratively, interpersonal skills to work across matrixed organization, very good written and verbal communication
– Interface with existing LMS systems ((Saba, QUMAS, Veeva) and migrating into Success Factors. Can learn these systems on the job if have worked in other systems.
– Solid understanding of the principles of Change Management
– 5 years’ experience minimum
– Involved with hands on execution in addition to oversight responsibilities

OBJECTIVES:
• Support the management of Change Management and Communications activities for Submissions Excellence, including its creation and implementation, including any documents and marketing tools and modes for deployment (developer/point person/ and PM) including training support and development
• Complete project activities, and development of plan to ensure comprehensive Change Management, Communications, and Training are synched and aligned with newly identified ways of working (Submissions Excellence)
• Provide metrics as requested to reflect project progress through data gathering to highlight impact on GRA ensuring program progression.
• Establish relationships within and across Global Regulatory Affairs (GRA) functions, driving collaboration, and alignment to ensure pro-grams are implemented successfully

RESPONSIBILITIES:
• The Manager Change Mgt, will work within the Submissions Excellence workstream to ensure alignment with all Future Fit activities. This position will work with the Sr. Manager of Change Mgt. and develop practices and complete objectives that impact on GRA system integration and implementation projects, including new ways of working.
• This role is responsible for driving the development of the change management workstream, driving engagement, developing change management products and solutions, including change activities and communications across GRA and its partners. This role will also actively identify and create training needed to support these endeavors.
• Support R&D Future Fit as it relates to GRA and Submissions Excellence beginning 1Q 2022.
• Support Doc. workflow management for all identified docs associated with various systems currently in use, ensuring updating, alignment, and retirement as required.
• Implement curricula strategy and needs that match to new ways of working identified within SubEx program, within eDMS and LMS systems as required to embed newly identified process and procedure.
• Support integration initiatives and workstream activities (as requested) from training and documentation administration. (VEEVA Vault, QUMAS eDMS systems)

REQUIREMENTS:
• Experience within a regulatory/compliance life sciences organization (preferred) focused on training, development and change management.
• Experience with eDMS (Doc Mgt) & LMS (Learning Mgt) systems (QUMAS/VEEVA/SABA) desired.
• Experience working with internal and external stakeholders and staff to support program workflows
• Experience with Microsoft products, survey tools, and website development required
• Ability to work within matrixed teams, and support objectives to completion.
• Ability to multi task, and work within a timeline
• Exceptional verbal and written communication skills critical

SKILLS:
• Suitable understanding of the pharmaceutical industry and the regulatory requirements.
• Suitable understanding of the Regulatory Compliance function.
• Comprehensive understanding of change management and communications principles
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
• Demonstrated ability to work across functions, regions and cultures
• Excellent communicator, able to accurately convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can produce credibility and confidence within and outside the company
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
• Invests time in helping others to enhance their skills and perform at a higher level
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
• Decision making responsibilities:
o Provide input to highly complex decisions that impact the functional area
• Accountable for providing input to and implementing vision and strategy for designated scope of activities
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Cultivates a broad network of relationships throughout the organization, with affiliates and external partners, in the industry and area of expertise.
• Ability to build strong relationships and collaborate effectively with other interfacing functions
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
• Ability to work in a global ecosystem (internal and external) with a high degree of complexity

EXPERIENCE AND EDUCATION:)
• Bachelor’s degree (or equivalent) required.
• 3 + years experience in Pharmaceutical industry, with Regulatory Affairs R&D, or Quality/Compliance preferred.
• Knowledge and understanding of the principles of change management
• Experience developing corporate communications supporting projects and programs
• Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
• Knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets.
• Practical operational experience of working across disciplines and across multiple regions. Experience working with-in a global team framework and a multi-cultural environment.
• Ability to critically analyze complex and/or ambiguous information and the impact on products and process.
• Ability to effectively communicate complex issues both verbally and in writing.
• Ability to work independently, multitask, and work within a timeline
• Exceptional verbal and written communication skills

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