Associate Director, Submissions Content Source Management Business Operations Lead (Hybrid role - onsite 3 days per week required)

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. 

Specific responsibilities of this position include:

• 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, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, C