Principle responsibilities may include, but are not limited to the following, and may vary depending on experience or assignments as determined by Johnson and Johnson Regulatory Operations (JJRO):

Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence

Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.)

Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable Asia Pacific Health Authority requirements

QC electronic and paper submissions to ensure compliance with company and applicable Asia Pacific Health Authority requirements

Maintain openly, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission

Participate on special projects and process improvement initiatives, as needed

Cultivate ongoing effective relationships with publishing contributors in the Cross sector

Provide technical training and/or guidance to submission contributors on submission requirements, standards and processes to facilitate efficient processing by agencies Communicate priorities as defined by the business (e.g., Pharm, Medical Device, Vision Care and Consumer)

Ensure established end-to-end submission processes, including use of ePOD are executed and applied for Johnson and Johnson Regulatory Operations (JJRO) supported submissions (e.g. submission excellence and planning)

Drive end-to-end (GRAIL) submission excellence processes and standards

Define and execute technical, publishing and production strategy with publishing team


REGULATORY AFFAIRS COMPETENCIES AND KNOWLEDGE:

Good working knowledge of Global Johnson & Johnson Systems i.e., Microsoft Word, Adobe, PDF Manipulation Tools i.e. ISI Toolbox, and related submission publishing tools (i.e. Insights Publisher) required

Experience with document formatting, word processing, use/applications of templates and ensuring submission readiness (i.e. bookmarking, hyperlinking and navigational aids) preferred

Sound understanding of information management concepts and tools needed to support business area preferred

Practical understanding of evolving technologies in support of business area preferred

Technical skills and experience to solve publishing/document processing issues preferred

Exceptional interpersonal, teamwork, and communication skills required

Exercises good judgment and communicates effectively with varied levels of the organization required

Follow established dossier procedures and standards as directed primarily by supervisor or dossier leader within the context of the submission plan.

Priorities are normally designated by supervisor with specific task-oriented direction provided on new or higher complexity assignments.

Overall priorities are normally designated by supervisor with incumbent exercising a moderate level of autonomy and judgment on work assignments and priorities within the context of the submission process, may work to resolve moderate-to¬ complex publishing-related issues for assigned products with management support, as needed.



Qualifications

• Proven track record in people management
• Exceptional demonstration of project management
• Manage complexity
• Team leadership
• Achievement/results orientation
• Resource planning and management
• Communication
• Concern for quality and order
• Flexibility, information seeking
• Process efficiency capabilities

Primary Location
China-Beijing-Beijing-
Organization
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Submissions
Requisition ID
1905764234W