Merck Director Compliance Officer-Global Medical Affairs in Upper Gwynedd, Pennsylvania
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.
The Merck Research Laboratories (MRL) Compliance Officer is responsible for the planning, management and independent oversight of compliance activities within Global Medical Affairs (GMA). S/he will pro-actively support client teams in the effective execution of business practices by partnering with them in setting and consulting on policies, promoting compliant behaviors, raising issues, and supporting corrective action. The compliance activities in this area are related to internal and external requirements, as well as driving business ownership of compliance within those organizations. S/he demonstrates and is recognized for having subject matter expertise in the relevant guidance, policies, codes, and regulations, as well as a thorough understanding of GMA business needs, strategic objectives, and operational practices. The Compliance Officer applies this expertise in advising and counseling clients on new issues and assisting in the implementation and enhancement of the Compliance Program within GMA.
Provide independent oversight for the compliance of GMA globally for both Field and Headquarter activities related to internal and external requirements.
Identify areas of potential compliance risk for GMA, develop a compliance plan and partner with GMA to develop action items that proactively address potential compliance risk for GMA.
Advise, provide guidance, and drive compliance ownership to leaders within GMA.
Work collaboratively with GMA, MRL Quality Assurance, as well as the Office of General Counsel to ensure that annual compliance, assessment and audit activities are executed successfully within designated time frames.
Implement and maintain policies and procedures designed to ensure that GMA activities are executed in accordance with compliance requirements.
Coordinate with GMA leadership to ensure periodic review and updates, as needed, of all guidance documents.
Independently applying expertise in advising and counseling clients on new issues, answering routine questions regarding policy, and assisting in the assessment and implementation of new activities
Engage in close collaboration with Region and Country Legal & Compliance personnel and client areas to ensure effective development and implementation of Headquarter-driven and regional scientific and medical activities.
Actively participate in and lead project teams; critically review all data and documents to ensure compliance requirements are met.
Lead/co-lead projects that have been identified as a high priority.
Maintaining full line-of-sight (from strategic intent through tactical execution) when supporting line management in the development of new or refined guidance to ensure that they are relevant, appropriate, and implementable. Steps include gathering input, liaising with Office of General Counsel, providing guidance, developing communications plans, and working with GMA to integrate the guidance into new or existing training.
Developing strong working relationships with key stakeholders in GMA as well as other parts of MRL, and throughout the Ethics & Compliance Organization.
Education Minimum Requirement:
Advanced degree preferred.
Required Experience and Skills:
High degree of ethics and integrity
Minimum of 8 years relevant experience, including pharmaceutical industry experience, compliance, quality or audit experience, legal experience, or some combination thereof.
Strong business-oriented focus and ability to drive behavioral change, implementation of new processes and procedures, training to support compliance and audit requirements.
An understanding of regulations and ethical guidelines relevant to the pharmaceutical industry, to ensure compliance with these external as well as internal guidelines and standard operating procedures.
Ability to see complex issues and projects from start to finish with strong personal integrity.
Excellent interpersonal, communication and presentation skills.
Demonstrated ability to maintain confidentiality of sensitive compliance and department issues.
Experience/comfort working with senior managers, Office of General Counsel and external regulatory agencies.
Self-motivated and pro-active
Experience with the development or execution of written policies, guidance, laws, rules or regulations or other significant drafting or writing experience
Training or presentation experience in individual or group situations
Ability to influence without authority and exercise good judgment
Ability to apply knowledge to real world situations
Ability to translate and communicate complex concepts clearly
Strong judgment and decision-making skills related to compliance related topics
Preferred Experience and Skills:
Some experience working in Medical Affairs and/or Compliance preferred, but not required.
Experience with pharmaceutical operations outside the US or experience in oncology considered a plus.
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.
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Job Compliance Officer
Other Locations: NA-US-NJ-Kenilworth
Title: Director Compliance Officer-Global Medical Affairs
Primary Location: NA-US-PA-Upper Gwynedd
Requisition ID: COM000889
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