Director, Submissions Content Source Management Business Operations Lead
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply common principles to the cross-functional processes to maintain minimum system complexity while providing high value efficiencies. The Lead will collaborate with cross-functional stakeholders on a daily basis, monitor and evaluate current state, facilitate change planning and drive implementation.
Specific responsibilities of this position include:
Function as Business System Owner (BSO) of the next generation global submission content management solution, and drive its implementation as part of the overall GRACS Information Management Strategy.
Lead Change Management and Business Process activities to drive adoption of the new global submission content management solution (REDS)
Proactively monitor use of the submission content source management system and facilitate process/system change design by receiving input on cross functional business needs
Own the business requirements as the BSO and make decisions on requirements and design topics
Support functional areas in identification and review of process questions and issues related to submission content management, quality and standards compliance
Engage across functional areas to identify opportunities for improvement; support the execution of improvement initiatives including business process design, coordination of IT activities, change management and training
Partner with QA and Standards to ensure the content management solution and its associated templates and interfaces adhere to company standards and meet business process requirements
Develop and evaluate metrics as part of a data monitoring plan to determine where process improvements or training may be required
Participate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for account creation and pre-approved change management
Provide guidance and leadership for M&A activities as it relates to submission content source management; partner with IT and cross-functional SMEs on migration projects
Minimum Education Requirement:
Bachelor’s degree with a minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a Master’s Degree and a minimum of 8 years of industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment
Required Experience and Skills:
Knowledge of the regulatory submission processes, systems, and business requirements
Experience with content management systems, preferably Documentum-based systems (FirstDoc, OpenText)
Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools
Knowledge of system development lifecycle and data administration concepts
Demonstrated experience assessing and enabling process change, especially with cross-functional teams in customer (client) facing roles
Ability to lead and influence others outside of a direct reporting relationship
Broad organizational awareness and knowledge of touch points/interdependencies
Demonstrated Change Management experience, including developing business processes and training documentation
Process Management Knowledge (e.g., Green Belt)
Project Management Skills
Demonstrated capabilities managing and mentoring staff
Strong communication skills (written and verbal), organizational skills and attention to detail
Advanced knowledge and capabilities applying technology within a business environment
Sigma Black Belt, Change Management Certification, PMI Certification.
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., Rahway, 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.
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Expected salary range:$159,200.00 - $250,700.00
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