北京招聘

POSITION SUMMARY:

This position is responsible for executing the electronic publishing of regulatory submissions for Health Authority in the Asia Pacific Region.

The primary focus is on regulatory submissions of paper, NeeS & eCTD format with the different levels complexity of submissions assigned based on experience, demonstrated technical skills and competencies or as part of a development opportunity. Responsibilities may include but are not limited to:

Electronically compile submission dossier structures and published output in both, electronic & non-eCTD format based on established dossier plan for assigned products, submission types, in collaboration with Johnson & Johnson Regulatory Operations (JJRO) Submission Managers and key business stakeholders.

Ensure relevant submission excellence processes are applied from submission publish and production of regulatory submissions are complete, properly formatted, and comply with Cross Sector-specific (Pharm, Medical Device, Vision Care & Consumer) regulatory requirements as appropriate

Perform various submission support activities including submission QC and component-level publishing for files in Portable Digital Format (PDF) per submission-readiness requirements and in conformance with J&J standards and practices, as needed

Participate in independent or team-based projects focused primarily on process improvement initiatives or the testing and implementation of new submission-related technologies

PRINCIPAL RESPONSIBILITIES:

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.

DESIRED TECHNICAL COMPETENCIES:

· 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

REPORTING RELATIONSHIPS:

This position will report to the Johnson and Johnson Regulatory Operations (JJRO) Manager. From a day-to-day operational perspective, the incumbent may receive supervision and oversight by a Submission Management Manager and/or Site Lead depending upon the particular organization site-specific considerations where the incumbent may reports to Director, within Johnson and Johnson Regulatory Operations (JJRO).

EDUCATION, EXPERIENCE AND QUALIFICATION REQUIREMENTS:

· University/Bachelor’s Degree or equivalent experience required.

· Proven track record in the full lifecycle of Regulatory Operations and a minimum of 2 - 4 years of working experience in regulatory submission planning and operations in Pharmaceuticals, Medical Devices or Consumer,

Cross-sector experience a plus.

· Ability to work with various stakeholders, including Global counterparts.

· English & country-specific (i.e., Mandarin in China; Thai in Thailand) language fluency required.

.作为亚洲领先的整体人才解决方案服务商，科锐国际在中国大陆、中国香港、印度、新加坡等亚洲地区拥有超过60家分支机构，1,000余名专业招聘顾问，在超过18个行业及领域为客户提供中高端猎头、招聘流程外包、灵活用工、营销外包、校园招聘、培训、招聘咨询等解决方案。在过去19年中，科锐已与2,000余家跨国集团、国内上市公司、快速成长性企业及非盈利组织建立长期合作关系。2014年，科锐国际成功为企业推荐的中高级管理及专业技术职位超过20,000名，全风险灵活用工人次超过40,000。

与超过2000家著名跨国及中资企业长期合作。其中70%为外资、25% 为快速成长民营、5%为国有。然而，更令我们引以为豪的是客户对我们的忠诚度，75%为重复购买客户，其中大量服务期逾10年。