At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
North Ryde, New South Wales, Australia, Singapore, Singapore
Job Description:
Senior Manager, Workstream Lead Regulatory-Transcend, MedTech APAC
Johnson & Johnson Ltd., is recruiting for a Senior Manager, Workstream Lead – Regulatory. This position is preferred to be based in J&J MedTech office in Singapore but open to other JNJ Offices in APAC.
The Johnson & Johnson MedTech Companies have been working to improve surgery for more than a century. With relevant breadth and depth in surgical technologies, orthopedic and interventional solutions, we seek to improve and enhance medical care for people worldwide. Together, we are working to craft the future of health through differentiated products and services.
The Senior Manager, Workstream Lead – Regulatory is a member of the MedTech APAC TranSCend ERP program organization and will report into the End to End Workstream Leader.
The Role is accountable to define, harmonize, and deliver Global ERP capabilities design and deployment for APAC Regulatory business process scope while proactively highlighting and mitigating risks impacting delivery.
Key responsibilities include but not limited to,
· Define the holistic business scope, including satellite system and cross workstream integrations. Evaluate inclusions / exclusions of new processes and prioritization of backlogs.
· Identifying gaps with the Global template and driving resolution to address those gaps.
· Accept/reject/reprioritize requirements using standard templates; escalate scope changes to PMO as needed.
· Translate business requirements into Business User Stories and partner with Technical teams to deliver systems solutions.
· Monitor solution build readiness, participate in demos, define mitigation plans and escalate risks to PMO.
· Lead Business Simulation Testing (BST), ensure comprehensive business scenarios, manage resources to meet test schedules, drive defect resolution and prioritization.
· Align on data cleansing scope and ownership; approve/reject changes to migration rules and scope; escalate migration risks.
· Approve end-user lists, position mappings, and role/security ownership.
· Ensure SOD conflicts are addressed; communicate organizational impacts and obtain business alignment.
· Support training strategy with Business Adoption Team
· Define business cutover/hypercare strategies with Cutover Lead, align activities, owners, and timelines and serve as main contact for business owners within the workstream
· Track hypercare metrics, identify deviations, and drive corrective actions.
· Collaborate with GPO, SME, IT, and PMO on planning and prioritization of any process design and build requirements.
· Use process design methodology, including relevant templates, tools, methodology, controls, and cadence to drive comprehensive solutions within the scope of the project
· Drives definition, documentation, and alignment of capabilities across the key stakeholder groups
· Reviews and approves end user business adoption mitigations for process changes
· Deviations from Standard ERP or Template, requires leadership review and approvals
· Partner with other functional teams to ensure a well-rounded end-to-end solution
· Partner with IT team to drive capabilities that are systematically crafted, built, validated, and deployed
· Collaborate with master data team to ensure data configuration meet business capability needs
· Partner with project management office to establish coordinated project plans / schedules / results.
· Partner with business adoption team to ensure organizational change, business readiness, site readiness, and training are delivered to meet business needs.
Qualifications
Education: Minimum of a bachelor’s degree.
Experience and Skills:
Required:
Minimum of 5 years of relevant experience in workstream minimum of 10 years of overall business experience within associated functions: Plan, Source, Make, Quality, Deliver, Logistics, Regulatory or Analytics.
Minimum of 3 years of business process transformation, process design and optimization experience.
Minimum of 1 cycle of hands-on ERP implementation experience in a sophisticated business and multi-ERP/system environment.
Experience in building consensus and ability to negotiate trade off decisions across the organization.
Proven understanding of MedTech Supply Chain.
Strong and tried project management experience.
Strong customer focus (internal & external), including development and management of collaborators.
Knowledge of deploying standardized work processes, tools, and templates.
Exhibit strong communication and organizational change skills.
Ability to build partnerships and collaborate both internally and externally.
Exhibits outstanding business and digital competence
Exihibit initiative in innovative ways to challenges in a fast-paced, changing global environment.
Preferred:
An Advanced degree or MBA.
Familiarity with GxP and SOX requirements and regulations as applicable for Workstream
Certification in areas of expertise (e.g., PMP, APICS, Lean/Six Sigma /Process Excellence, etc.).
Other:
[Position requires up to 25% domestic and international]
Required Skills:
Regulatory Inspections, Regulatory Negotiations, Regulatory Reporting, Regulatory Requirements, Regulatory Submissions
Preferred Skills:
Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility
