Head of clinical ra Job at Randstad (苏州市)

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

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

Ks1 Supply Primary Teacher

Exciting Opportunity for a KS1 Supply Primary Teacher! Are you a versatile educ...

Location

United Kingdom , Crawley

Salary:

Not provided

Randstad

Expiration Date

July 01, 2026

Requirements

Qualified Teacher Status (QTS) or equivalent
Experience or a passion for teaching KS1 students
Adaptability and flexibility to work in different classroom settings
Strong communication skills and the ability to engage students effectively

Job Responsibility

Delivering pre-prepared lessons and activities in an engaging and supportive manner
Establishing a positive and inclusive classroom environment that encourages active participation and learning
Supporting student's academic and social development in the absence of the regular class teacher
Collaborating with school staff to ensure a seamless transition during temporary assignments

What we offer

Opportunities to work in a supportive and diverse educational setting
Competitive pay rates and flexible working arrangements
Valuable experience in various classroom environments

Parttime

Supply Teacher

Join Our Team of Inspiring Supply Teachers - Flexible Opportunities Available! A...

Location

United Kingdom , Gatwick

Salary:

140.00 - 150.00 GBP / Day

Randstad

Expiration Date

July 01, 2026

Requirements

Qualified Teacher Status (QTS) or equivalent teaching qualification
Enhanced DBS on the update service (or willingness to obtain one)
Strong understanding of the primary curriculum (KS1 & KS2) and a passion for fostering student growth
Flexibility, strong communication skills, and a positive attitude

Job Responsibility

Deliver engaging lessons that inspire and motivate students
Adapt to different classroom environments and teaching styles with ease
Build meaningful relationships with students and staff, contributing to a positive learning atmosphere
Ensure continuity of education by following lesson plans and maintaining classroom management

What we offer

Flexibility to choose when and where you work
Diverse experience in a variety of schools
Supportive environment with dedicated consultant
Competitive daily rates of pay with weekly payments
£300 referral bonus for bringing teaching friends
No lesson planning required
Opportunities for professional development and career advancement

Parttime

Patient Access Liaison

The Patient Access Liaison (PAL) is a field-based patient access and reimburseme...

Location

United States , Oklahoma City

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of patient services and/or access and reimbursement experience OR Bachelor's degree and 4 years of patient services and/or access and reimbursement experience OR Associate's degree and 8 years of patient services and/or access and reimbursement experience OR High school diploma / GED and 10 years of patient services and/or access and reimbursement experience
Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience OR Master's degree and 4 years of patient services, and/or access and reimbursement, experience OR Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience

Job Responsibility

Serve as a resource on patient access and reimbursement for infused and specialty therapies
Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
Provide education regarding coding and billing considerations relevant to therapy access
Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
Secure written or electronic patient HIPAA authorization within assigned geography
Assess individual patient needs and provide education and resources that support access to therapy
Educate patients on coverage considerations and the steps required to obtain prior authorization
Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Housekeeper

Location

United States , Bloomington

Salary:

15.00 - 18.00 USD / Hour

Atria Senior Living

Expiration Date

Until further notice

Requirements

Basic reading, writing, and mathematical skills
Communicate effectively in English with employees and residents
General knowledge of sanitation and safe food handling practices
Ability to retain orders (up to four at one time)
Strong organization and time management skills
Basic computer skills

Job Responsibility

Maintain the Community interior, including residents’ apartments, in a clean and sanitary fashion and in a courteous and friendly manner
Provide general housekeeping for both the Community as a whole and individual resident apartments
Clean and defrost refrigerators, clean and check heat system filters, change bed and linens, ensure adequate linen supplies in each apartment
Turn mattress as necessary and empty waste baskets
Provide deep cleaning of apartments as needed
Launder all linens
Follow Company sanitation and safety procedures
Greet residents and guests at each table to serve beverages, cereals, and soups/salads
Review menu, take resident orders, serve meals and desserts
Return cart to kitchen and assist with storage of perishable items

What we offer

Competitive Pay
Paid Holidays & PTO
Comprehensive Health Plans (medical, vision, dental, company paid short term and long term disability, other voluntary benefits such as critical illness coverage)
Career Advancement Opportunities
Tuition Reimbursement up to $5,250 a year
Employee Loyalty Rewards Program
Retirement Savings Plan with Employer Match (50% match on a percentage of savings after one year)
Rewards & Recognition
Health & Safety

Fulltime

Estimating And Pricing Lead

At Boeing, we innovate and collaborate to make the world a better place. We’re c...

Location

United States , El Segundo; Los Angeles

Salary:

127500.00 - 172500.00 USD / Year

Boeing

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher
5+ years of experience in a finance related position such as Financial Operations, Material Cost Management, Accounting, Estimating, Financial Planning, or Procurement Financial Analysis (PFA)
5+ years of experience with Microsoft Office including Outlook, PowerPoint Word and Excel
Willing to travel domestically as needed

Job Responsibility

Leads development of estimates and prices from technical requirements through the design, build, and aftermarket support stages of the program
Develops, prepares and validates estimates and prices
Evaluates requests for proposal, substantiates estimates/pricing and assembles price proposals
Develops estimating and pricing methods
Evaluates and develops cases
Performs analyses and provides recommendations in support of pricing/estimating (risk, financial, etc.)
Incorporates data into and maintains structured systems and coordinates program database requirements
Develops solutions to problems of unusual complexity that require a high degree of ingenuity, creativity, and innovation
Develops solutions to unique challenges that may serve as precedent for future decisions
Recognized as a job expert within the company and consultant to top management

What we offer

Generous company match to your 401(k)
Industry-leading tuition assistance program pays your institution directly
Fertility, adoption, and surrogacy benefits
Up to $10,000 gift match when you support your favorite nonprofit organizations
health insurance
flexible spending accounts
health savings accounts
retirement savings plans
life and disability insurance programs
paid and unpaid time away from work

Fulltime

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Head of clinical ra

Job Description

Requirements

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