2. Own the process on booking and delivering the stationary and name card.
3. Manage couriers and mail services by onsite service provider.
4. Manage conference usage and coordinate the conflict between users in case it happens.
5. Monitor office cleaning and schedule for special action to maintain office with a clean, comfortable and safe environment.
6. Assist manager with space management and seating assignment according to company standard.
7. Responsible for other administration issue.
1. College or above graduate.
2. Conscientious and careful.
3. Good customer service awareness, supportive and proactive attitude.
4. Strong interpersonal skills, good team player.
5. Process management.
6. Ability to work under pressure.
1. 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.
2. QC electronic and paper submissions to ensure compliance with company and applicable health agency requirements.
3. 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.
4. Participate on special projects and process improvement initiatives, as needed.
5. Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas.
1. Regulatory Affairs competencies and proficiency levels vary based on role and may include: Applied Technical Knowledge, Business Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing, and Persuasive Communication.
2. Therapeutic area and product knowledge, understanding of drug development process preferred.
3. Demonstrated project or submission management capabilities preferred.
4. Experience in pharmaceutical industry submission publishing or related technical skills required.
5. Familiarity with Industry trends and forums, FDA and/or EU, and ROW regulations & guidelines required.
6.Good working knowledge of Document Management Systems i.e. Documentum, Microsoft Word, Adobe, PDF Manipulation Tools i.e. ISI Toolbox, and related submission publishing tools (i.e. Insights Publisher) required.
7. Experience with document formatting, word processing, use/applications of templates and ensuring submission readiness (i.e. bookmarking, hyperlinking and navigational aids) preferred.
8. Sound understanding of information management concepts and tools needed to support business area preferred.
9. Practical understanding of evolving technologies in support of business area preferred.
10. Technical skills and experience to solve publishing/document processing issues preferred.
11. Exceptional interpersonal, teamwork, and communication skills required.
12. Exercises good judgment and communicates effectively with varied levels of the organization required.
13. Demonstrated ability to work effectively in a matrix environment preferred.