Senior Specialist, Regulatory Submission Manager Job - United States
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 125-year legacy. 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.
Regulatory Portfolio and Submissions Management works closely with various stakeholders of regulatory/safety submissions to drive the identification, planning, resourcing, execution, and management of activities that deliver high quality and timely/regulatory submissions. The position will be responsible for independently managing regulatory and safety submission projects, at any level of complexity, across all submission types.
The incumbent is expected to be skilled in project management with a strong track record of demonstrated leadership on cross-functional regulatory teams. 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 Portfolio and Submissions Management processes and deliverables.
Regulatory Project Management (~90%)
- Build and drive regulatory cross- functional teams focused on the identification, planning, and execution of regulatory and safety submissions, with an end-to-end mindset.
- 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 or issues that could impact the successful completion of submissions.
- 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 functional areas to assess collection of submissions to manage sequencing and possible execution issues, as needed.
- Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables.
- Monitors team dynamics regularly to ensure optimal team performance. Take action to correct problems within a team stemming from miscommunication, differences of opinion, misaligned objectives, inexperience, etc.
Process Improvements / Talent Development (~10%)
- Actively lead and/or participate in continuous improvement activities including business processes, tools, systems, metrics and analytics
- Take advantage of opportunities to increase knowledge of the discipline of project management and understanding of drug/vaccine/biologics development and regulatory practices in the pharmaceutical industry and to improve leadership skills.
- Bachelor’s degree
- Ability to lead by influence and work effectively in matrix organizational structures
- 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 3 years of working experience within a healthcare/consumer care industry project management, regulatory affairs, and/or pharmacovigilance/risk management function.
- Experience with managing successful delivery of regulatory submissions
- Advanced degree preferred (engineering or scientific discipline, MBA)
- Technically skilled in project management methodologies (e.g., PMP)
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: Regulatory Affairs Generic
Job Title:Sr. Spclst, Regulatory Affairs
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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