Head of clinical ra Job at Randstad (苏州市)

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Japan Regulatory Strategy Manager

Amgen is a global leader in biotechnology with a history of more than four decad...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
Advanced degree preferred
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to lead effective teams
Ability to work in matrix environments including cross-functional and global teams

Job Responsibility

Developing and executing the regulatory strategies and plans
Providing strategic regulatory expertise for drug development
Interfacing with regulatory authorities
Aligning with key cross-functional partners
Integrating into Amgen's commercialization process
Continuously improving business processes
Developing and implementing the Japan regulatory strategy, aligned with global regulatory strategy
Providing guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influencing developing the global regulatory strategy so that Japan developments are aligned
Consistently looking for opportunities to accelerate the developments/approval and/or increase the value of the program

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Japan Regulatory Strategy Manager

Japan Regulatory Affairs provides leadership, expertise, and execution for the r...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy

Job Responsibility

Develops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy so that Japan developments are aligned
Consistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients
As a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan
Ensures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
Ensures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

New

Barback Busser

Our jobs aren’t just about putting food on the table that our guests will enjoy ...

Location

United States , Austin

Salary:

17.15 USD / Hour

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or G.E.D. equivalent
No related work experience
Previous experience in a food and beverage environment preferred

Job Responsibility

Setting tables
Assisting the kitchen
Cleaning work areas
Replenishing supplies
Creating a safe workplace
Following company policies and procedures
Upholding quality standards
Ensuring uniform, personal appearance, and communications are professional
Standing, sitting, or walking for an extended time
Moving over sloping, uneven, or slippery surfaces

Fulltime

New

Bar Back

Our jobs aren’t just about putting food on the table that our guests will enjoy ...

Location

United States

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or G.E.D. equivalent
No related work experience
Previous experience in a food and beverage environment preferred
No supervisory experience
None

Job Responsibility

Setting tables
assisting the kitchen
cleaning work areas and replenishing supplies
creating a safe workplace
following company policies and procedures
upholding quality standards
ensuring your uniform, personal appearance, and communications are professional
managing the menu (read and visually verify information)
moving, lifting, carrying, pushing, pulling, and placing objects weighing less than or equal to 25 pounds without assistance and 50 pounds with assistance
reaching overhead and below the knees, including bending, twisting, pulling, and stooping

Parttime

New

Spa Supervisor

Complete designated cashier and closing reports in the computer system. Review s...

Location

Bermuda

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or G.E.D. equivalent
Minimum of 2 years of related work experience
At least 1 year of supervisory experience

Job Responsibility

Complete designated cashier and closing reports in the computer system
Review shift logs/daily memo books and document pertinent information in logbooks
Contact appropriate individual or department as necessary to resolve guest call, request, or problem
Process all guest check-ins by confirming reservations, verifying guest identity, requesting form of payment, assigning room, and activating and issuing room key
Sell room/accommodation to guests without reservations based on availability
Ensure rates match market codes and exceptions are documented
Assist management in training, evaluating, counseling, disciplining, motivating and coaching employees
Serve as a role model and first point of contact of the Guarantee of Fair Treatment/Open Door Policy process
Report accidents, injuries, and unsafe work conditions to manager
Complete safety training and certifications

Fulltime

New

Recreation Attendant

Location

United States

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or G.E.D. equivalent
No related work experience
No supervisory experience
CPR Certification
First Aid Certification
Recreation Equipment
Any certification or training required by local and state agencies

Job Responsibility

Encourage, recruit, register, and schedule guests to participate in recreation activities
Promote a fun and relaxing atmosphere for guests
Provide information to guests about available recreation facilities and activities
Promote the rules and regulations of the recreation facility intended for the safety and welfare of guests and members
Observe activity in the recreational facility and respond appropriately in accordance with local operating procedure in the event of an emergency
Be aware of possible situations where guests are not able to safely participate in an activity and inform supervisor/manager
Clean and maintain recreational equipment and supplies
Report accidents, injuries, and unsafe work conditions to manager
complete safety training and certifications
Follow company policies and procedures

Fulltime

New

Chef-Pastry

Exhibits creative baking and decorating talents by personally performing tasks w...

Location

Dominican Republic , Cap Cana

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or GED
4 years experience in the culinary, food and beverage, or related professional area
OR 2-year degree from an accredited university in Culinary Arts, Hotel and Restaurant Management, or related major
2 years experience in the culinary, food and beverage, or related professional area

Job Responsibility

Exhibits creative baking and decorating talents by personally performing tasks while leading the staff in preparing quality and consistent pastries for all areas
Works to continually improve guest and employee satisfaction while maintaining the operating budget
Leads development and training of team to improve results while maintaining standards
Must ensure sanitation and food standards are achieved
Utilizes interpersonal and communication skills to lead, influence, and encourage others
Advocates sound financial/business decision making
Demonstrates honesty/integrity
Leads by example
Supervises and manages employees
Manages all day-to-day operations

Fulltime

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Head of clinical ra

Job Description

Requirements

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