Director Medical Affairs Operations | Process and Systems

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio.

The Director, Medical Affairs Operations, Process and Systems is a leadership role within Global Medical Affairs Capabilities (GMAC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Senior Director (SD) Global Medical Operations Lead and is an integral member of the GMAC Medical Operations Leadership Team providing insight and advice on strategic direction and held accountable for assisting and driving execution of the vision of Medical Operations.

This role is responsible for managing people and building optimal teams and talent and instills operational discipline by leveraging a quality systems mindset and approach for our key GMSA processes. The successful candidate will lead several core GMSA global initiatives, including, but not limited to: Scientific Leader Engagement | Local Data Generation (LDG) | Medical Information. In addition, will also have the responsibility in furthering the vision of our Process Architecture in enabling our GMSA organization capability via processes and systems that are customer focused, effective, and compliant.

Responsibilities

Leadership

• Understands the mission and vision of GMSA as a science-driven and patient-committed organization

• Manages, leads, and supports professional development of GMAC Process and Systems team

• Stays current with key initiatives across GMAC Medical Operations and supports fellow leadership colleagues and their teams in achieving deliverables against organizational priorities

• Understands and executes end-to-end people and performance management activities (i.e. mid- and year-end reviews, ongoing feedback, talent management, succession planning, recruitment and retention)

• Oversees complex initiatives with global scope and impact aligned with key GMSA Medical Operations priorities

• Exhibits a high degree of collaboration with GMAC Medical Operations and other GMAC colleagues to ensure alignment across the broader organization

• Partners with members of the broader Process and Systems network in Global Clinical Development, Research and Development (R&D), and our company to identify operational efficiencies

• Presents ongoing strategic project updates at GMSA leadership team meetings as well as at other relevant forums (e.g. Summits, Townhalls, Operations Reviews, Priority Project meetings)

• Exhibits executive presence, deep subject matter expertise and strong business acumen

Process & Systems

• Partners with GMSA Process and Systems lead, other team members, and GMSA information technology (IT) in developing the GMSA technology strategy/roadmap and manages implementation and steady state operations, including systems/technologies. Examples may include scientific leader (SL) engagement, medical information, local data generation (LDG), patient programs, and GMSA communication platform

• Participates in the development and management of the global MA compliance operations capability to provide “one-view” of compliance to senior leadership, to manage risk, and to deliver solutions (policies, procedures, monitoring, and training) that focus on business efficiencies while maintaining compliance

• Participates in the business/IT governance structure, ensuring accountability and enabling the predictability of the outcomes of each transformation initiative

• Ensures organizational alignment in the design and execution of initiative efforts (key result areas are process assurance and improvement, communication and change management, and continuous improvement performance management)

• Provides strategic leadership through facilitating fit for purpose processes and enabling technology solutions. Partners with cross functional/cross matrix team using change management approach in implementing harmonized processes and technology for global GMSA colleagues

• Guides the development of effective assessment and remediation frameworks and/or practices

• Ensures coordination between the regions, Therapy Areas to drive consistency in approach and implementation and develop mechanisms/forums for best practice sharing around the world

• Manages and refreshes the portfolio of work required to reduce operational risk by simplifying processes

• Charters initiatives, leads, mentors, and executes project work in the areas of SL engagement, data generation, and medical information

• Conducts operational excellence assurance visits and reports results to appropriate personnel and management, ensuring corrective actions are taken to bring observations to closure

• Participates in Global Process Assurance and Accountability efforts to ensure consistency in GMSA processes across countries

• Collaborates with Standards Alignment team as appropriate to understand and address audit findings that impact processes and systems

• Collaborates/partners with country medical colleagues to ensure global processes, tools, and training are adding effectiveness and compliance value at the local level

• Creates and provides oversight for a measurement system and/or tool to assess awareness, understanding, buy-in, and support of change management activities

Education

• Bachelor degree in Life Sciences, Business, or Healthcare or Master degree

Experience and Skills

Required

• Minimum five years relevant Medical Affairs or equivalent related experience (e.g. Process and Systems, Medical Operations)

• Relevant process and systems implementation and improvement

• Partnering with business stakeholders across geographies, therapy areas, and functions to inform global process design and implementation

• Lead process and systems workshops, interviews, and other methodologies to inform effective, efficient, new, and updated processes and systems

• Working with and within cross-functional teams to ensure that all areas and supporting functions (e.g., IT, Human Resources, Finance) are well represented and align with project goals and the program vision

• Deep understanding of the environment, evolution and global nature of Medical Affairs

• Strong personal integrity and high ethical standards

• Managing people and high performing teams

• Ability to organize, prioritize, and work effectively in a constantly changing, ambiguous environment and to motivate a team to do the same

• Leading cross-functional, global initiatives in a complex matrix environment, with strategic networking and cross-functional management skills

• Strong decision-making, problem-solving and analytical skills, with ability to innovate with practical solutions for complex issues

• Ability to work independently while escalating risks and issues as appropriate

• Working within regulations and compliance requirements.

• Principled interpersonal verbal and written communications and presentation capabilities

Preferred

• Working at affiliate, regional, and global level

• Certification in Change Management, Sigma, and Project Management

• Successful leadership history and ability to deploy Operational Excellence principles

• Change management and project management skills, with the ability to work effectively and drive alignment in a global environment through strong communication and empowerment

• Audits with major regulatory agencies, representing functional processes

• Ability to design/facilitate workshops (Kaizen) and problem-solving sessions to simplify key processes

• Effectively communicate information at executive management level

• Strong judgment, prioritization, and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies

• Demonstrated ability to motivate, mentor, manage, and provide clear, unambiguous expectations and priorities for the team – of own staff or through networks. Comfort and confidence working with diverse teams and backgrounds

• In a matrix environment, ability to effectively collaborate with and influence partners across divisions; ability to collaborate with others to resolve conflicts across organizations

• Process Analysis and Design

• Systems Design and Implementation

• Operations Management

• Content Management Processes, Service Center/Call Center Processes, Medical Information Processes

• Systems: Veeva Vault MedComms, Service Cloud or Veeva Medical Information, VEEVA Medical CRM

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Requisition ID:R160018