Associate Director, Regulatory Submission Manager
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 biopharmaceutical 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.
Under the guidance of the Program Director (M3), Regulatory Planning and Execution (RPE), this position will be responsible for both regulatory and safety submission projects and managing, developing and mentoring Regulatory Report Coordinators and Submission Managers. Additionally, the incumbent may be involved leading or supporting within or cross departmental process improvement or strategic initiatives designed to improve the efficiency and effectiveness of the Regulatory Submissions Management processes and deliverables.
Roles within Regulatory Submission Management will ensure that business value / business impact are assessed on an ongoing basis with the appropriate stakeholders across the various groups that support or are impacted by regulatory planning and execution across our research, manufacturing, and global human health divisions.
Primary Activities
Staff Management (~50%)
• Manage and develop approximately 6 or more direct reports in any type of regulatory/safety submissions with a keen commitment to providing value. Expectations are that the incumbent will also coach their staff in the concepts, methods and nuances of document/project management, drug development, and regulatory/safety operations.
• Use sound judgment in determining what level of management is needed for a given project and effectively guides direct reports on the level of support required for project needs. Provide technical guidance and oversight to direct reports, ensuring they understand priorities and issues in relation to their projects.
• Operate well individually in the face of ambiguity and translates this leadership among their staff in order to contribute to efficient forward progress as a department. Work with other People Managers to ensure that best practices are being employed across projects, including conducting post reviews to learn what worked and what did not, in order to drive continuous improvement
• Collaborate with other project management groups within the division(s) to share best practices and improve the quality of the project model for regulatory/safety submissions.
• Administrative management includes working with staff as follows:
• Set appropriate objectives and monitor against these
• Ensure employees have meaningful discussions on Employee Development Plans on an ongoing basis
• Ensure compliance with training, policy and procedures
• Conduct effective calibration of employees and provide objective and honest assessments
Project Management (~50%)
• Independently manage projects, irrespective of portfolio, phase, complexity, priority, or involvement with a partner.
• Build and drive cross- functional / divisional teams focused on the identification, planning, and execution of regulatory submissions, with an end-to-end mindset.
• Is a proactive and creative problem-solver that generates options, makes effective and timely decisions and can skillfully negotiate to resolve conflicts.
• Ensure that team meetings have structure and clear purposes and goals; facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team.
• Identify, assess and actively resolve or escalate where necessary any risks that could impact the successful completion of projects.
• Independently identify gaps and propose solutions and approaches to address; lead efforts to solve/develop process and structure as appropriate.
• Actively manage timelines including a clear understanding of dependencies and critical path.
• Ensure project data, including information used to maintain compliance and aid with submissions planning, are accurately reported in databases and understood by stakeholders.
• For assigned products, works closely with portfolio managers and functional areas to assess collection of submission projects to manage intersections, opportunities for bundling, needs for sequencing and possible execution issues, as needed.
• Assist in the development and continuous improvement of business processes, tools, systems, metrics and analytics. Share knowledge and expertise across portfolios, projects, functional areas.
Requirements:
Education Minimum Requirement: Bachelor's degree required
Experience and Skills –
• Extensive experience managing cross-functional teams and track record of effective collaboration with noted ability to lead by influence and work effectively in matrix organizational structures
• Experience with leading successful delivery of projects in the regulatory space (pipeline, submission, business improvement, and/or change management projects)
• Skilled in the management of complex project plans and executes with a sense of urgency.
• Technically skilled in project management methodologies (e.g. PMP, Sigma, or Change etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
• Is a proactive and creative problem-solver that generates options, makes effective and timely decisions and can skillfully negotiate to resolve conflicts
• Demonstrated ability to collaborate, communicate, and coach across cultures, organizational levels and disciplines.
• Effective at energizing others, establishing clear goals, delegating responsibility, mentoring and coaching within a team setting
• Well developed and effective team facilitation and leadership skills; able to establish cooperative team environments
• Ability to understand details, but keep overall "big picture" view of projects and strategies
• At least 8 years of working experience with or within a healthcare/consumer care industry project management or regulatory affairs function.
Desired Experience and Skills –
• Advanced degree preferred (engineering or scientific discipline, MBA)
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .
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.
