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

Senior Marketing Design Lead

Our client is looking to hire a Senior Marketing Design Lead who will play a key...

Location

United States , Arlington

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

8+ years of experience in marketing design, brand design, or digital creative roles
Proven experience leading or mentoring designers within a collaborative environment
Strong portfolio showcasing modern, high-quality work across multiple digital channels
Expertise in Figma and Adobe Creative Suite
Deep understanding of typography, layout, visual systems, and storytelling
Experience building scalable design systems and repeatable frameworks
Strong communicator with the ability to influence across teams and stakeholders
Ability to balance strategic thinking with hands-on execution in a fast-paced environment

Job Responsibility

Lead, mentor, and develop a team of marketing designers, providing guidance, feedback, and support for growth
Partner closely with senior creative leadership to shape and execute the overall creative vision
Design and oversee work across web, landing pages, social, email, CRM, and other digital experiences
Establish and uphold high design standards across brand expression, consistency, and execution
Contribute hands-on to key campaigns and initiatives, setting the bar through your own work
Build and scale design systems, templates, and reusable components across marketing channels
Collaborate cross-functionally with marketing, product, and content teams to deliver cohesive customer experiences
Leverage data, insights, and user behavior to continuously optimize creative performance
Help define workflows, processes, and operating models to improve team efficiency and collaboration

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

New

HR Generalist

We are looking for an HR Generalist to support a retail organization in Southlak...

Location

United States , Southlake

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

3-5 years of human resources experience in a generalist or closely related role
Strong communication and relationship-building skills with the ability to coach employees and managers effectively
Hands-on experience with HRIS and payroll platforms such as Workday, ADP Workforce Now, Ceridian, or Dayforce
Working knowledge of compliance practices related to employee records, benefits administration, workers' compensation, and leave management including FMLA
Ability to manage sensitive information with discretion and maintain a high level of integrity
Proficiency with computer systems and the ability to learn new HR tools and processes quickly
Entry-level candidates with strong potential, a detail-oriented mindset, and a willingness to learn may also be considered

Job Responsibility

Review and resolve discrepancies involving employee records, payroll, benefit vendors, and government agencies to help maintain accurate documentation and regulatory alignment
Administer workers' compensation matters, leave requests, and mandated time-off programs while ensuring proper follow-up and compliance with applicable requirements
Respond to employee questions related to benefits and provide clear guidance so team members can make informed decisions about available programs
Evaluate and recommend benefit enhancements or employee-focused perks that support engagement and overall satisfaction
Partner with managers on day-to-day employee relations matters, including performance concerns, workplace conflict, and appropriate resolution strategies
Support initiatives that encourage a productive, respectful, and positive work environment across the organization
Help implement HR programs and practices designed to improve workplace efficiency and reduce employee relations issues
Maintain HR data and documentation within HRIS platforms and related systems to support reporting, consistency, and operational effectiveness

What we offer

medical, vision, dental, and life and disability insurance
enrollment in our company 401(k) plan

New

Application Support Technology Lead Analyst

The Apps Sup Tech Lead Analyst is a strategic professional who stays abreast of ...

Location

India , Chennai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

6-10 years experience
Practical problem solving and strategic thinking skills
Demonstrated leadership, interpersonal skills and relationship building skills
Service oriented attitude
Ability to work in a fast-paced environment
Experience working or leading requirement gathering efforts for multiple large development projects at one-time
Proficient using basic technical tools and systems
Good interpersonal and communication skills
Strong functional knowledge of Investment banking and Settlement/Metrics & Client Reporting and Asset Servicing business
Proven experience supporting business critical applications in a global markets or trading environment

Job Responsibility

Partner with multiple technology teams to ensure appropriate integration of functions to meet goals
identify and define necessary system enhancements
analyze existing system logic, identify problems
and recommend and implements solutions
Provides expertise in area and an advanced level of understanding of the principles of apps support
Formulates and defines systems scope and objectives for complex, high impact application enhancements and problem resolution through in-depth analysis and evaluation of complex business processes, systems and industry standards
documents requirements
Partners with multiple technology areas and management teams to ensure appropriate integration of functions to meet goals
Works closely with Product Owners, Business Analysts and Systems Analysts to determine and document Systems impacts and support requirements
Considers the implications of the application of technology to the current environment

Fulltime

New

HR Generalist

We are looking for an experienced HR Generalist to support a healthcare organiza...

Location

United States , San Diego

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

2-3 years of HR Generalist experience, with direct involvement in accommodations and leave of absence administration
Working knowledge of employment law, compliance standards, and HR best practices related to workplace accommodations and protected leave
Experience supporting employee relations matters, including investigations and performance or disciplinary discussions
Strong written and verbal communication skills with the ability to explain HR processes clearly to employees and managers
Analytical problem-solving ability and sound judgment when addressing sensitive workplace situations
High level of confidentiality and professionalism in handling employee information

Job Responsibility

Oversee accommodation requests by partnering with employees and managers, explaining available options, assessing workplace needs, and recommending appropriate solutions
Support leaders in evaluating operational impact related to accommodation requests and help document decisions regarding potential hardship considerations
Manage leave of absence cases from intake through follow-up, ensuring employees and supervisors understand timelines, documentation, and next steps
Coordinate leave administration with internal payroll and benefits partners to maintain accurate records and consistent employee support
Advise managers and staff on HR policies, compliance expectations, and best practices related to employee concerns and workplace matters
Contribute to employee relations activities by assisting with investigations, performance-related issues, and corrective action processes
Maintain confidential HR information with a high level of discretion while preparing clear and accurate documentation
Use HR systems and tools, including ADP platforms, to support personnel administration and reporting needs

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

New

Commis De Rang

We currently have an opportunity for a Commis De Rang to join our iconic hotel, ...

Location

Italy , Milano

Salary:

Not provided

Four Seasons

Expiration Date

Until further notice

Requirements

Food service experience in luxury hotels and/or stand-alone restaurants or restaurant groups, preferably in the same position and international experience would be an asset
Attention to detail
Strong interpersonal and relationship building skills
Ability to multi-task with excellent organizational skills
Team player
Bring personal touch and energy to guest experiences
Passion for excellence
Legal right to work in Italy
Fluency in English and Italian

Job Responsibility

Assisting the Chef de Rang
Serving of food
Set-up and clearing of china, glass, and silver
Attending to guest needs and requests
Being highly visible in the operation
Providing an expertly service experience
Clearing and resetting tables according to standards
Respecting the Hygiene standards applied in the Restaurant as per HACCP system

What we offer

Competitive Salary, wages, and a comprehensive benefits package
Excellent Training and Development opportunities
Complimentary Dry Cleaning for Employee Uniforms
Meals available at our Employee Restaurant
Employee Experience initiatives from annual themed employee party to many ESG events throughout the year
Employee Recognition Programs
Opportunities to build a successful career with global potential

Fulltime

Select Country

Head of clinical ra

Job Description

Requirements

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