Merck
Associate Director, Submissions Content Source Management Business Operations Le
Merck, Bohemia, New York, United States, 11716
Overview
THIS IS A HYBRID ROLE - REQUIREMENT TO WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK) 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. Responsibilities
Function as Business System Owner (BSO) of the current Documentum-based global submission content management solution Co-lead the implementation of the next generation Veeva Vault RIM-based global content source management solution and function as BSO Lead the Change Management and Business Process activities to drive adoption of the new solution Support daily operations of the current Documentum-based submission content source management system and the cross-functional user base 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 Our Company and Health Authority standards and meet business process requirements Develop and evaluate metrics as part of a data quality 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 Education
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 with the implementation and operations of a modern Veeva RIM Vault Knowledge of the regulatory submission processes, systems, and business requirements 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 Preferred
Experience with other content management systems such as Documentum Advanced knowledge and capabilities applying technology within a business environment Sigma Black Belt, Change Management Certification, PMI Certification Required Skills
Adaptability, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking Preferred Skills
Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights, and EEOC GINA Supplement pages. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, with Friday remote unless business critical tasks require on-site presence. This guidance does not apply to roles that are remote or other exemptions.
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THIS IS A HYBRID ROLE - REQUIREMENT TO WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK) 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. Responsibilities
Function as Business System Owner (BSO) of the current Documentum-based global submission content management solution Co-lead the implementation of the next generation Veeva Vault RIM-based global content source management solution and function as BSO Lead the Change Management and Business Process activities to drive adoption of the new solution Support daily operations of the current Documentum-based submission content source management system and the cross-functional user base 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 Our Company and Health Authority standards and meet business process requirements Develop and evaluate metrics as part of a data quality 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 Education
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 with the implementation and operations of a modern Veeva RIM Vault Knowledge of the regulatory submission processes, systems, and business requirements 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 Preferred
Experience with other content management systems such as Documentum Advanced knowledge and capabilities applying technology within a business environment Sigma Black Belt, Change Management Certification, PMI Certification Required Skills
Adaptability, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking Preferred Skills
Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights, and EEOC GINA Supplement pages. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, with Friday remote unless business critical tasks require on-site presence. This guidance does not apply to roles that are remote or other exemptions.
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