Hispanic Alliance for Career Enhancement
Associate Director, Submissions Content Source Management Business Operations Le
Hispanic Alliance for Career Enhancement, Rahway, New Jersey, us, 07065
Job Description
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 A MUST!
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, 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
Location Requirements 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Salary The salary range for this role is $126,500.00 - $199,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
Equal Employment Opportunity 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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
#J-18808-Ljbffr
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 A MUST!
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, 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
Location Requirements 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Salary The salary range for this role is $126,500.00 - $199,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
Equal Employment Opportunity 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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
#J-18808-Ljbffr