Executive Director, Research & Development Compliance Global Medical and Scientific Affairs

Job Description

Overview:

This role serves as a key member of our company's research division Ethics & Compliance Leadership Team and as a trusted counselor and advisor to the Global Clinical Development (GCD) organization, with particular focus on the Value and Implementation (V&I) team. The Executive Director reports to, and partners closely with, the head of our company's manufacturing and research divisions Compliance, representing the Ethics & Compliance Office (ECO) in counseling senior leaders within GCD and V&I.

The Executive Director is accountable for the execution of key compliance initiatives and is tasked with understanding and advising on the legal and practical implications of those initiatives on GCD and V&I activities. The Executive Director will serve as a subject matter expert in the relevant policies, guidance documents, codes, and regulations that impact GCD and V&I business needs, strategic objectives, and operational practices. The Executive Director applies this expertise in advising and counseling clients, including Senior Management, and assisting in the assessment and implementation of activities.

The Executive Director leads a team of three people based in the United States and Europe.

What this role will do:

• Provide compliance counseling and advice to stakeholders in GCD and V&I globally, including by serving as a member of the V&I Extended Leadership Team and acting as the Compliance point for the leader of the V&I organization.
• Provide strategic oversight, engage in data monitoring and analysis, and develop practical, risk-based recommendations in support of GCD and V&I initiatives and activities.
• Present to Senior Management on relevant compliance matters, including on external events that may impact internal compliance needs.
• Counsel the V&I organization, as well as relevant stakeholders in Human Health that interact with V&I, in the management of the risks inherent in their respective business operations.
• Support the V&I and GCD teams in the effective execution of compliant business practices by partnering in the development of our company's research division policies, promotion of compliance messaging, and implementation of corrective actions, as needed.
• Collaborate with colleagues across our company's research division Compliance to support our company's research division Compliance Monitoring Plan to proactively identify and address potential risks for the division.
• Support due diligence for later-stage business development and, as needed, integration activities for closed acquisitions.
• Partner closely with colleagues across ECO and International Legal and Compliance to ensure effective development and implementation of HQ-driven and cross-regional GCD and V&I practices.
• Work to build strong teams and talent within the compliance organization.

Requirements:

• BA/BS required; advanced degree in science, business, or policy preferred
• J.D. from a US-accredited law school (or ex-US equivalent) strongly preferred
• Minimum of 15 years of experience with knowledge and comprehension of laws, regulations, and policies guiding the conduct of business practices within the pharmaceutical industry, particularly in the medical affairs space (e.g., advertising/promotion regulations; AKS; FCPA) and an ability to apply knowledge to real-world situations
• Experience counseling clients and a demonstrated ability to appropriately influence decision-makers, including Senior Leaders, on legal/compliance issues in the life sciences area
• Strong analytical skills, with the ability to anticipate and identify potential compliance risks with proposed activities and develop effective mitigation strategies
• Solid judgment and disciplined decision-making coupled with emotional intelligence and an effective counseling style
• Strong written/oral communication and presentation skills, including the ability to convey complex concepts clearly and simply
• Willingness to travel as needed to support compliance initiatives globally
• Ability to build collaborative relationships with stakeholders, including the ability to work across functions, divisions, and geographies
• Familiarity with our company's research and human health organizations and activities
• Experience with the development or execution of written policies and guidance
• Experience leading and developing teams or an enthusiasm for people management

Required Skills:

Compliance Program Development, Compliance Reporting, Cross-Cultural Awareness, Detail-Oriented, Ethical Compliance, Exercises Judgment, Leadership, Metrics Analysis, People Management, Policy Implementation, Regulatory Compliance Audits, Regulatory Reporting, Stakeholder Management, Technical Documentation Management, Training and Development

Preferred Skills:

Regulatory Compliance

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