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

Assistant Director of Video Services

K-State Athletics is seeking qualified applicants for an Assistant Director of V...

Location

United States , Manhattan

Salary:

47500.00 - 50000.00 USD / Year

Kansas State University

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent combination of education and training beyond high school, with an emphasis in professional video production, broadcast media, sports media, digital media, or a related field
Strong proficiency in Adobe Premiere Pro, Adobe After Effects, and Adobe Photoshop
Bachelor's degree in video production, broadcast media, sports media, communications, or a related field
Minimum of one year of full-time experience in a collegiate or live-event video production environment
Working knowledge of Ross Video Kiva, Expression, and Acuity systems
Daktronics Show Control
EVS Replay systems
and Yamaha audio boards
Strong verbal and written communication skills with the ability to collaborate effectively across departments and production teams
Demonstrated ability to perform in a fast-paced, high-pressure live production environment while meeting deadlines and adapting to last-minute changes with strong attention to detail

Job Responsibility

Plan, develop, edit, organize, and manage creative content for videoboards and other in-venue display systems
Manage all game day control room operations, including production setup, supervision of student and freelance crew members, live event directing, and overall execution of in-venue videoboard productions
Oversee operation and content management of Daktronics display systems across all athletic venues, ensuring proper functionality and timely content updates
Perform additional duties and special projects as assigned

What we offer

Excellent medical, dental and vision health plans
Retirement plan (No Vesting Period!!)
Generous earned leave plan – vacation and sick
Parental leave plan
Term life insurance
Accidental death and dismemberment insurance
Long term disability insurance
Paid KSU designated holidays

Fulltime

New

Government Contracting Specialist

As a Government Contracting Specialist at Air Space Intelligence, you will overs...

Location

United States , Boston

Salary:

Not provided

Air Space Intelligence

Expiration Date

Until further notice

Requirements

7+ years of experience in federal government contracting, procurement, or contract administration
Strong knowledge of FAR/DFARS and federal acquisition processes
Experience supporting contracts with agencies such as the DoD, FAA, NASA, DHS, or related organizations
Familiarity with software, SaaS, aerospace, aviation, or defense technology environments
Experience with a wide range federal contract vehicles
Excellent organizational and project management skills
Strong written communication and proposal coordination abilities
Ability to manage multiple concurrent deadlines in a fast-paced environment
A bias for action and the ability to operate independently
Intellectual curiosity and a desire to continuously learn and improve

Job Responsibility

Oversee and support the full lifecycle of government contracting activities across a portfolio of federal customers and strategic partners
Play a critical role in helping Air Space Intelligence navigate and grow within the defense, aerospace, and federal technology ecosystem
Work closely with business development, engineering, finance, legal, and executive leadership teams to support contract execution, proposal development, compliance, and strategic customer engagement across agencies including the DoD, FAA, DoT, NASA, DHS, and the U.S. Coast Guard
Advocate for advantageous contracting and acquisition solutions with government customers
Support pricing strategy development and proposal structuring
Assist with pricing documentation, representations and certifications, and compliance matrices
Support RFP, RFQ, and RFI responses, teaming agreements, and proposal submissions
Provide contracting expertise to shape competitive and compliant proposal strategies
Manage the lifecycle of federal contracts, subcontracts, task orders, and contract modifications
Ensure compliance with FAR, DFARS, agency supplements, OTAs, and contractual requirements

Fulltime

New

Quality Engineer

We are a leading developer and manufacturer of mechanical and electronic locking...

Location

Poland , Tychy

Salary:

Not provided

Huf Hülsbeck & Fürst GmbH & Co. KG

Expiration Date

Until further notice

Requirements

Higher technical education
Minimum 2 years of professional experience in a similar role within the automotive industry
Knowledge of technical drawings and quality tools (Ishikawa, Pareto, correlation diagrams, FMEA, SPC, 3D reports)
Ability to work in a team and excellent self-organization skills
Very good command of German and/or English
Knowledge of DoE and/or TRIZ methodology would be an advantage

Job Responsibility

Analyzing and resolving ongoing quality issues, both internal and external, related to the production process and product
Communicating with customers in case of quality issues and participating in audits and customer visits to improve process and/or product quality
Supporting the planning and approval of new product and process launches, both in the development and serial production phases
Developing and verifying quality documentation at every stage of the production process
Ensuring implementation of customer requirements and monitoring their fulfillment

Fulltime

New

Enterprise Integration Developer

The Enterprise Integrations Developer will frequently collaborate with teammates...

Location

United States , Manhattan

Salary:

80000.00 - 85000.00 USD / Year

Kansas State University

Expiration Date

June 19, 2026

Requirements

High school diploma (or equivalent) and six years of relevant experience
Five or more years of relevant experience including some combination of the following: Experience in APIs, streaming data services, and/or message queue development
Data Integration concepts and strategies: ETL, EL-T, Data Warehousing, event-based processing
Database knowledge in SQL, Oracle, MySQL, or PostgreSQL
Mentoring and leading by example
Excellent oral and written and communication skills
Critical thinking ability
Excellent logical, analytical, and strong problem-solving capacity
Able to find root causes of problems and quickly determine efficient solutions
Personable and able to work in a team environment and respectfully interact with technical and non-technical users

Job Responsibility

Collaborate with teammates for enterprise integrations needs through creative, innovative, and timely solutions
Assist in the development of data integration procedures across large, complex, and multiple systems through data movement solutions
Data system optimization by searching for effective data gathering techniques to support business functions and production operations
Take charge of problems, and take the initiative to design and deliver solutions

Fulltime

New

Sr. Accounting Manager – Pharmacy Services Accounting

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Cumberland

Salary:

82940.00 - 182549.00 USD / Year

CVS Health

Expiration Date

June 05, 2026

Requirements

7+ years of experience in accounting, finance, consulting, or transformation work
Strong understanding of accounting processes
Experience leading or supporting process improvements or transformation efforts
Familiarity with ERP systems (like SAP or Oracle)
Bachelor's degree in Accounting, Finance, OR equivalent experience
CPA or MBA preferred

Job Responsibility

Managing core accounting activities (especially month-end close)
Improving processes and driving automation within finance
Leading projects that modernize and make accounting operations more efficient
Lead the month-end close process for SG&A expenses
Review journal entries, reconciliations, and controls for accuracy and compliance
Ensure processes follow US GAAP and company policies
Improve and standardize accounting and reporting processes
Lead projects to improve efficiency, scalability, and consistency in finance
Help implement new tools, systems, or automation
Partner with teams across the organization to roll out improvements

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs
Bonus, commission or short-term incentive program
Equity award program

Fulltime

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Head of clinical ra

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